Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 13, 2023

Elanco Animal Health Incorporated

(Exact name of registrant as specified in its charter)

Indiana

001-38661

82-5497352

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer

Identification Number)

2500 Innovation Way

Greenfield, Indiana

(Address of principal executive offices)

46140

(Zip Code)

Registrant’s telephone number, including area code: (877) 352-6261

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, no par value		ELAN		New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

¨ Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

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

Exhibit 99.1

FOR IMMEDIATE RELEASE

Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com

Investor Contact: Kathryn Grissom (317) 273-9284 kathryn.grissom@elancoah.com

Environmental Protection Agency (EPA) Completes Review of Seresto^® Collar and Confirms Continued Registration; Data Affirms Safety Profile of the Product

	·	Comprehensive, multi-year review by the EPA, with support from the Food and Drug Administration, confirms Seresto continues to meet EPA standards for product registration
	·	Data affirms the safety profile of the product
	·	Expert toxicologists and veterinarians voice their support of Seresto’s safety profile
	·	Elanco and EPA forge stewardship program expected to raise the bar for the flea and tick collar category

GREENFIELD, Ind. (July 13, 2023) – Elanco Animal Health Incorporated (NYSE: ELAN) and the U. S. Environmental Protection Agency (EPA) today announced that EPA, with support from the Food and Drug Administration (FDA), has completed its comprehensive, multi-year review of the Seresto® flea and tick collar. EPA confirms continued registration of the collar. Comprehensive data affirms the safety profile of Seresto.

As part of EPA’s scientific review process, the agency analyzed incident data including third-party assessments and compared data to other EPA-registered pet products. EPA’s conclusions found that the most frequently reported incidents were primarily dermatologic in nature, such as itching or redness around the collar site, which is consistent with previous findings. According to EPA, Seresto continues to meet all of EPA’s standards for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which ensures that products do not pose unreasonable risk of harm.

Following the comprehensive review, Elanco and EPA developed a stewardship program that Elanco will implement as a leader in the collar category. The program includes:

	·	Enhanced data collection for adverse event (AE) reports
	·	Continued annual enhanced reporting of Seresto AE data, similar to what EPA requires for pet spot-on products
	·	Outreach to the veterinary community
	·	Review of the collar release mechanism
	·	Separation of product registrations for dog and cat
	·	Updates to package insert language
	·	Five-year registration review to ensure stewardship program actions support the continued safe use of Seresto. Elanco will complete a renewal process near the end of this period.

Elanco encourages EPA to implement these measures as a new EPA standard across all flea and tick collars to ensure consistent expectations for reporting across the category, similar to the elevated standards the agency implemented in 2010 for pet spot-on pesticide products (products applied directly to the skin of pets for flea and tick control).

Since launch in 2013, more than 41 million Seresto collars have been sold in the U.S. Over this period, the reporting rate for all incidents related to Seresto has been low and trending downward. In 2022, the estimated incidence of adverse events in the U.S. following exposure to Seresto was approximately 0.116%, which equates to approximately 1 animal with a reported adverse event for every 1,000 collars distributed in the U.S., the majority of which relate to non-serious events such as itching or redness localized at the collar application site.

The EPA’s conclusions align with those of authorities worldwide, with Seresto being approved for use in more than 80 countries and supported by veterinary professionals around the globe. The robust scientific evidence – data generated prior to approval through present day, including ongoing post-market surveillance data, and broad use of more than 110 million collars around the world – further supports Seresto’s safe use.

“We appreciate EPA’s diligence during this data-driven review process, resulting in a clear outcome and continued product availability to protect pets and human health,” said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco. “We stand behind more than a decade of science-based data, analysis and monitoring which affirms the safety profile of Seresto. As a leader in animal health, we are committed to the well-being of pets and welcome the opportunity to work with EPA to implement these stewardship actions. We expect these actions to raise the bar for flea and tick collars and support the continued safe use of Seresto to protect pets from fleas and ticks and the deadly diseases they carry.”

According to the Center for Disease Control and Prevention (CDC), tickborne disease cases have increased 25% from 2011 to 2019.ⁱ The Companion Animal Parasite Council (CAPC) recommends preventing contact between pets and parasites by using products that kill and/or repel ticks.ⁱⁱ

Veterinary and Toxicology Experts Voice Their Support for Seresto

Veterinary and toxicology experts around the country have been vocal in their support of Seresto. With the EPA review complete, experts share their thanks for giving pet owners the closure and confidence they need during what has started as a heavier than normal flea and tick season.

“Our Pet Poison Helpline data and experience supports the overall safety profile of Seresto. The health protections these collars provide by protecting pets from dangerous diseases that fleas and ticks carry far outweigh the extremely rare risk of a serious adverse event,” says Dr. Ahna Brutlag, Veterinary Toxicology Expert from Pet Poison Helpline, a national animal poison control center.

ⁱTrends in Reported Babesiosis Cases — United States, 2011–2019 | MMWR (cdc.gov)

ⁱⁱCompanion Animal Parasite Council | 2023 Annual Pet Parasite Forecasts (capcvet.org)

In-clinic veterinarians also continue to voice their support of Seresto as a convenient, dependable and affordable option for consumers.

“This conclusion from EPA comes at a critical time as pet owners need to be thinking about protecting their pets from pests during this heavy flea and tick season. As a veterinarian and pet owner myself, I know the importance of protecting both pets and humans from risks associated with fleas and ticks,” said Dr. Lisa Lippman, practicing veterinarian. “With the Seresto collar, the substantial body of scientific evidence continues to support its strong safety profile and effectiveness to provide eight continuous months of protection against fleas and ticks which can transmit dangerous diseases, such as Lyme disease. Seresto offers a much-needed, cost-effective option for protection. That’s why I fully support and use Seresto and recommend it to pet owners for usage year-round.”

Numerous studies and incident data analyses have concluded that Seresto has a strong safety profile and does not pose an unreasonable risk, which is why the American Veterinary Medical Association has expressed support for Seresto’s continued EPA registration.

ABOUT ELANCO

Elanco Animal Health (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we’re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability, Elanco Healthy Purpose™– all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

Exhibit 99.2

Seresto® Stewardship Program On July 13, 2023, Elanco Animal Health Incorporated 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. EPA confirms continued registration of the collar. Comprehensive data affirms the safety profile of Seresto. Following the comprehensive review, Elanco and EPA developed a stewardship program that Elanco will implement as a leader in the collar category. The program includes: Enhanced data collection for adverse event (AE) reports – Elanco is implementing additional training for relevant personnel to enhance data collection for AE reporting to ensure best efforts to capture patient information, such as pre-existing medical conditions, medications concomitantly administered, previous uneventful history with the product and patient health status where an attending veterinarian is involved. Continued annual enhanced reporting of Seresto AE data – Elanco’s existing pharmacovigilance and regulatory affairs teams will report AE and sales data for Seresto to EPA using standard agency templates on an annual basis, similar to what EPA requires for spot-on products. Outreach to the veterinary community – Elanco will utilize existing relationships and digital tools to share information with the U.S. veterinary community around the benefits, as well as possible risks, associated with use of pesticides, including Seresto, and the importance of reporting adverse events. Review of the collar release mechanism – Elanco will assess functionality of and potential modifications to the release mechanism to optimize performance. Analysis will be provided to EPA within one year. Separation of product registrations for dog and cat – Elanco has established a new registration for Seresto Cat. The existing EPA registration will remain for Seresto Dog. This change will allow for more granular adverse event evaluation. Updates to package insert language – Elanco has created species specific product labels (dog and cat) and updated package insert language to include additional information on potential adverse events. Existing Seresto inventory to be sold with no expected commercial disruption or material financial impact related to the change. Five-year registration review to ensure stewardship program actions support the continued safe use of Seresto – For the next five years, utilizing its existing pharmacovigilance and regulatory affairs teams, Elanco will submit an annual report to EPA, providing an update on stewardship efforts and an analysis of safety information collected the preceding year to ensure these stewardship efforts support the continued safe use of Seresto. Elanco will complete a renewal process near the end of this period.

Cover	Jul. 13, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 13, 2023
Entity File Number	001-38661
Entity Registrant Name	Elanco Animal Health Incorporated
Entity Central Index Key	0001739104
Entity Tax Identification Number	82-5497352
Entity Incorporation, State or Country Code	IN
Entity Address, Address Line One	2500 Innovation Way
Entity Address, City or Town	Greenfield
Entity Address, State or Province	IN
Entity Address, Postal Zip Code	46140
City Area Code	877
Local Phone Number	352-6261
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, no par value
Trading Symbol	ELAN
Security Exchange Name	NYSE
Entity Emerging Growth Company	false