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Item 9A. Controls and Procedures

2025-11-25 compared with 2024-12-11 · 40 added, 73 removed, 186 unchanged (38% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

An evaluation was carried out by Embecta’s management, with the participation of Embecta’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of Embecta’s disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934) as of September 30, 2024.

Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the design and operation of these controls and procedures were, as of the end of the period covered by this Annual Report on Form 10-K, not effective due to a material weakness in the Company's internal control over financial reporting related to the design and operation of certain process and management review controls, including management's review activities for account reconciliations and analyses that were executed for the first time during fiscal year 2024 subsequent to the first and second phases of the Company's ERP system implementation which is further described below.

Based upon that evaluation as of September 30, 2025, the Company’s Chief Executive Officer and Chief Financial Officer each concluded that the design and operation of these disclosure controls and procedures were, as of the end of the period covered by this Annual Report on Form 10-K, effective and ensure that material information relating to Embecta and its consolidated subsidiaries would be made known to them by others within these entities.

In 2022, the Company commenced the process of implementing a new ERP system and other Business Continuity Processes to replace the existing systems provided by BD.

The ERP system is designed to accurately maintain the Company's financial records used to report operating results.

The implementation of the ERP system and other Business Continuity Processes is highly complex and has occurred and will continue to occur in phases across our geographies.

The first phase of the implementation began in the fourth quarter of fiscal year 2023.

The second phase began in the first quarter of fiscal year 2024 and continued through fiscal year 2024 in North America, EMEA and Greater China.

The first and second phases of the implementation are now complete.

The remaining third and fourth phases include Latin America and India, respectively.

The third phase was completed in the first quarter of fiscal 2025.

The fourth and final phase is expected to be completed in fiscal year 2025 subsequent to the date of this Annual Report on Form 10-K.

A standardized internal control framework is implemented with each phase as the Company moves away from relying on BD’s systems and controls.

Since the fourth and final phase has not yet been completed as of the date of this Annual Report on Form 10-K, the Company continues to rely on certain processes and internal control over financial reporting performed by BD.

The implementation of the ERP system and other Business Continuity Processes is highly complex and has occurred in phases across geographies.

The implementations of North America, EMEA, Asia and Greater China were completed in phases within fiscal years 2023 and 2024.

The Latin America implementation was completed in the first quarter of fiscal year 2025 and the implementation for India, the final phase, was completed in the third quarter of fiscal year 2025.

A standardized internal control framework was implemented with each phase as the Company moved away from relying on BD’s systems and controls.

Management’s Responsibilities

9 unchanged sentences

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) under the Securities Act of 1934, as amended.

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) under the Exchange Act, as amended.

Management conducted an assessment of the effectiveness of internal control over financial reporting based on the criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework).

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.

In connection with the preparation and filing of this Annual Report on Form 10-K, the Company’s management, including our Chief Executive Officer and our Chief Financial Officer, conducted an evaluation of the effectiveness of its internal control over financial reporting as of September 30, 2024.

Based on this evaluation, management concluded that the Company's internal control over financial reporting was not effective as of September 30, 2024, due to a material weakness in its internal controls related to the design and operation of certain process and management review controls, including certain account reconciliations and analyses.

Subsequent to the first and second phases of ERP implementation, the Company instituted new Control Activities.

Specifically, these newly designed Control Activities were executed for the first time in fiscal year 2024.

Management has concluded that these newly designed Control Activities were not designed or operating effectively to ensure the appropriate level of management review, precision, and adequate evidence to confirm the completeness and accuracy of data used in the account reconciliations and analyses.

Notwithstanding the material weaknesses, management has concluded that the financial statements included elsewhere in this Annual Report on Form 10-K present fairly, in all material respects, our financial position, results of operations, and cash flows in conformity with GAAP.

In connection with the preparation and filing of this Annual Report on Form 10-K, the Company’s management, including the Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of its internal control over financial reporting as of September 30, 2025.

Based on this evaluation, management concluded that the Company's internal control over financial reporting was effective as of September 30, 2025.

The consolidated financial statements included in this Annual Report on Form 10-K and the effectiveness of the Company's internal control over financial reporting as of September 30, 2025 have been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report included in this Annual Report on Form 10-K.

See “Report of Independent Registered Public Accounting Firm” which is included in Item 8 of this Annual Report on Form 10-K.

Remediation Plan

Upon the identification of the material weakness, management immediately effectuated a plan to remediate the design and operation of the related Control Activities.

This plan has commenced and will continue into fiscal year 2025 and is intended to involve, but is not limited to, the following actions:

• reassess the design of processes and internal controls related to certain account reconciliations and certain analyses;

• execute a robust and formal training program regarding diligence in control performance and Sarbanes-Oxley Act requirements;

• implement enhanced oversight and governance over account reconciliations and certain financial analyses;

• enhance control documentation and design to include additional procedures regarding confirmation of the completeness and accuracy of data used to perform controls and the precision of control activities.

The Company is committed to remediating the material weakness.

The actions it is taking are subject to ongoing management review, as well as oversight from the Audit Committee.

When fully implemented and operational, the Company believes the measures described above will remediate the underlying cause of the material weakness and will strengthen the Company's internal control over financial reporting.

However, the Company will not be able to fully remediate this material weakness until these steps have been completed and have been operating effectively for a sufficient period of time.

The Company may also identify additional measures that may be required to remediate the material weakness in its internal control over financial reporting, necessitating further action.

The Company expects to complete the remediation plan in fiscal year 2025.

Remediation of Previously Reported Material Weakness

As previously disclosed in Embecta’s Annual Report on Form 10-K for the year ended September 30, 2024, the Company had identified a material weakness in the internal control over financial reporting related to the design and operation of certain process and management review controls, including management's review activities for account reconciliations and analyses that were executed subsequent to the completion phases of the Company's ERP system implementation which are further described above.

Management implemented the following activities to remediate the material weakness:

• evaluated the design of processes and internal controls related to account reconciliations affected by the material weakness;

• executed a robust and formal training program regarding diligence in control performance and Sarbanes-Oxley Act requirements and emphasis of certain finance policies;

• implemented enhanced oversight and governance over account reconciliations and financial analyses;

• enhanced control design and related documentation to include additional procedures regarding confirmation of the completeness and accuracy of data used to perform controls and additional documentation around the precision of control activities;

• leveraged existing technology to develop enhanced reporting and to drive process efficiencies and automation.

As of September 30, 2025, management has completed testing of the design and operating effectiveness of the Company’s internal control over financial reporting following execution of the remediation steps described above.

Accordingly, management has concluded that the previously identified material weakness is remediated as of September 30, 2025.

Changes in Internal Control over Financial Reporting

The Company is working towards executing the remediation plan to address the material weakness noted above.

However, none of these efforts have resulted in the remediation of the material weakness noted above as of September 30, 2024.

There have been no changes in its internal control over financial reporting during the fourth quarter of fiscal year 2024 other than the identification of the material weakness and the remediation plan disclosed above that have materially affected, or that are reasonably likely to materially affect, the Company's internal control over financial reporting.

Other than the remediation of the material weakness described above, there have been no changes in its internal control over financial reporting during the fourth quarter of fiscal year 2025, that have materially affected, or that are reasonably likely to materially affect, the Company's internal control over financial reporting.

Other Information.

As previously disclosed in the Company’s Current Report on Form 8-K filed with the SEC on December 2, 2024 (the “December 2, 2024 8-K”), the Company appointed Anthony Roth as Vice President, Chief Accounting Officer (“CAO” and “principal accounting officer,” as such term is used under the Exchange Act) and Corporate Controller of the Company on November 26, 2024, effective December 2, 2024.

The Company had anticipated filing this Annual Report on Form 10-K prior to the effectiveness of Mr.

Roth’s appointment, but was unable to do so due to the identification of the material weakness in the Company’s internal control over financial reporting related to the design and operation of certain process and management review controls, as further described in Part II, Item 9A of this Annual Report on Form 10-K.

As a result, the Company’s Board of Directors on December 10, 2024 retroactively postponed the effectiveness of Mr.

Roth’s appointment from December 2, 2024 to until after the filing of this Annual Report on Form 10-K.

Jake Elguicze, who is the

Chief Financial Officer of the Company and served as the principal accounting officer of the Company prior to Mr.

Roth’s appointment, served as the Company’s principal accounting officer until the filing of this Annual Report on Form 10-K .

Following the filing of this Annual Report on Form 10-K, Mr.

Roth’s appointment as CAO and principal accounting officer will become effective, and Mr.

Elguicze will step down as the Company’s principal accounting officer , but continue to serve as the Company’s Chief Financial Officer and principal financial officer.

Biographical, compensation and other information regarding Mr.

Elguicze is set forth in the Company’s proxy statement, filed with the SEC on December 19, 2023, under the section “Management,” and such information is incorporated by reference herein.

There is no arrangement or understanding between Mr.

Elguicze and any other person pursuant to which Mr.

Elguicze was selected as principal accounting officer , and there are no family relationships between Mr.

Elguicze and any of the Company’s directors or executive officers.

There have been no transactions involving Mr.

Elguicze that would be required to be disclosed by Item 404(a) of Regulation S-K.

Elguicze did not receive any additional compensation in connection with assuming the responsibilities of principal accounting officer .

Biographical, compensation and other information regarding Mr.

Roth is set forth in the December 2, 2024 8-K , and such information is incorporated by reference herein.

Not applicable.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

78 unchanged sentences

10.14 Form of November 2024 Employee and Director PSU and RSU Awards under the 2022 Employee and Director Equity-Based Compensation Plan and Conditions of Awards.

(Filed herewith.) (+)

( Incorporated by reference to the Company's Annual Report on Form 10-K filed on December 11, 2024 ) (+)

10.15 Letter Agreement, dated as of January 25, 2021, by and between BD and Devdatt Kurdikar.

28 unchanged sentences

Insider Trading Policy.

(Filed herewith.)

(Incorporated by reference to the Company's Annual Report on Form 10-K filed on December 11, 2024.)

21.1 List of Subsidiaries of Embecta Corp.

33 unchanged sentences

(Principal Executive Officer)

December 11, 2024

November 25, 2025

/s/ JACOB ELGUICZE

1 unchanged sentence

Senior Vice President, Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

December 11, 2024

(Principal Financial Officer)

November 25, 2025

/s/ ANTHONY ROTH

Vice President, Controller and Chief Accounting Officer

(Principal Accounting Officer)

November 25, 2025

Pursuant to the requirements of the Securities and Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

2 unchanged sentences

LTG (Ret.) David F.

Melcher Director December 11, 2024

Melcher Director November 25, 2025

and Chairman of the Board

Albritton Director December 11, 2024

/s/ CARRIE L.

Anderson Director December 11, 2024

Anderson Director November 25, 2025

/s/ ROBERT (BOB) J.

Robert (Bob) J.

Hombach Director December 11, 2024

Hombach Director November 25, 2025

/s/ MILTON M.

1 unchanged sentence

Morris, Ph.D.

Director December 11, 2024

Director November 25, 2025

/s/ CLAIRE POMEROY, M.D.

Claire Pomeroy, M.D.

Director December 11, 2024

Prange Director December 11, 2024

Director November 25, 2025

Prange Director November 25, 2025

/s/ CHRISTOPHER R.

Christopher R.

Reidy Director December 11, 2024

Reidy Director November 25, 2025

/s/ DEVDATT KURDIKAR

Devdatt Kurdikar President and Chief Executive Officer December 11, 2024

Devdatt Kurdikar President and Chief Executive Officer November 25, 2025

(Principal Executive Officer)

/s/ JACOB ELGUICZE

Jacob Elguicze Senior Vice President, Chief Financial Officer December 11, 2024

(Principal Financial Officer and Principal Accounting Officer)

Jacob Elguicze Senior Vice President, Chief Financial Officer November 25, 2025

(Principal Financial Officer)

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures