Embecta Corp. 10-Q

Item 1A. Risk Factors. There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2023 Form 10-K, except for the addition of the following risk factor: In the first quarter of Embecta’s fiscal year 2024, Embecta submitted its first 510(k) premarket filing to the FDA for its proprietary disposable insulin delivery system. We cannot predict when, if ever, such submission will be cleared by the FDA, as the FDA can refuse to grant a 510(k) clearance for many reasons, including the system may not be deemed by the FDA to be substantially equivalent to appropriate predicate devices under the 510(k) pathway, the system may not satisfy the FDA’s safety or effectiveness requirements, or changes in FDA clearance policies or adoption of new regulations may require additional data. Even if cleared by the FDA or foreign regulatory agencies, future generations of our systems, expanded indications for use of future systems, our software platforms or any other system under development, may not be cleared for the indications that are necessary or desirable for successful commercialization. Item 6. Exhibits. Exhibit Number Exhibit Description 10.1* Amendment No. 1 to the Embecta Corp. 2022 Employee and Director Equity-Based Compensation Plan 31.1* Certification of Chief Executive Officer, pursuant to SEC Rule 13a–14(a) 31.2* Certification of Chief Financial Officer, pursuant to SEC Rule 13a–14(a) 32.1** Certification of Chief Executive Officer, pursuant to Rule 13a–14(b) and Section 1350 of Chapter 63 of Title 18 of the U.S. Code 32.2** Certification of Chief Financial Officer, pursuant to Rule 13a–14(b) and Section 1350 of Chapter 63 of Title 18 of the U.S. Code 101* The following materials from this report, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) the Condensed Consolidated Statements of Income, (ii) the Condensed Consolidated Statements of Comprehensive Income, (iii) the Condensed Consolidated Balance Sheets, (iv) the Condensed Consolidated Statements of Equity, (v) the Condensed Consolidated Statements of Cash Flows, and (vi) Notes to Condensed Consolidated Financial Statements. 104* Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) * Filed herewith ** Furnished herewith Dollar amounts are in millions except per share amounts or as otherwise specified. 25 Table of Contents SIGNATURE 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. EMBECTA CORP. Date: February 9, 2024 By: /s/ Devdatt Kurdikar Name: Devdatt Kurdikar Title: President and Chief Executive Officer (Principal Executive Officer) Date: February 9, 2024 By: /s/ Jacob Elguicze Name: Jacob Elguicze Title: Senior Vice President, Chief Financial Officer (Principal Financial Officer) Date: February 9, 2024 By: /s/ Brian Capone Name: Brian Capone Title: Vice President, Controller and Chief Accounting Officer (Principal Accounting Officer) 26