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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. ¨
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.
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
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.
i
Trends in Reported Babesiosis Cases — United States, 2011–2019 | MMWR (cdc.gov)
ii
Companion 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. |
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