UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD. |
A copy of the press release issued by Elanco Animal Health Incorporated (the “Company”) announcing the completion of the review of the Seresto® flea and tick collar as described under Item 8.01 below is attached to this Current Report on Form 8-K as Exhibit 99.1. A related summary detailing the Seresto Stewardship Program described in the press release is attached as Exhibit 99.2. The Company does not expect any commercial disruption or material financial impact as a result of the announced stewardship program. The information in this Item 7.01, including the information contained in the accompanying Exhibits 99.1 and 99.2, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as otherwise expressly stated in such filing.
| Item 8.01 | Other Events. |
On July 13, 2023, the Company and the Environmental Protection Agency (EPA) announced that the EPA, with support from the Food and Drug Administration (FDA), completed its comprehensive, multi-year review of the Seresto® flea and tick collar. The EPA confirms continued registration of the collar. Comprehensive data affirms the safety profile of Seresto. Following the comprehensive review, Elanco and the EPA developed a stewardship program that Elanco will implement as a leader in the collar category.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including but not limited to statements about the expected impacts of the announced stewardship program. These forward-looking statements are based on the Company’s current expectations and assumptions regarding, among other things, the expected sales cadence of existing inventory over the next 12 months and the expected costs related to the stewardship activities. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Current Report on Form 8-K. The Company undertakes no duty to update forward-looking statements.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release issued by the Company on July 13, 2023. | |
| 99.2 | Summary of Seresto Stewardship Program issued by the Company on July 13, 2023. | |
| 104.1 | Cover Page Interactive Data file (embedded within the Inline XBRL document). |
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 hereunto duly authorized.
| ELANCO ANIMAL HEALTH INCORPORATED | ||
| Date: July 13, 2023 | By: | /s/ Todd Young |
| Name: Todd Young | ||
| Title: Executive Vice President and Chief Financial Officer | ||