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January 08 2024 - 5:00PM
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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):
January 8, 2024
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) | |
(I.R.S. Employer Identification No.) |
2500 Innovation Way
Greenfield, Indiana (Address of principal executive offices)
| |
46140 (Zip
Code) |
Registrant’s telephone number, including area code: (877)
352-6261
Not Applicable
(Former Name or Address, if Changed Since Last Report)
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 |
5.00% Tangible Equity Units |
|
ELAT |
|
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. ¨
On January 9, 2024, Elanco
Animal Health Incorporated (the “Company”) will present at the 42nd Annual J.P. Morgan Healthcare Conference (the
“JPM Conference”). A copy of the Company’s presentation is furnished as Exhibit 99.1.
The information in this Item
7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (“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, except as otherwise expressly stated in such filing.
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: January 8, 2024 |
By: |
/s/ Todd Young |
|
|
Name: |
Todd Young |
|
|
Title: |
Executive Vice President and Chief Financial Officer |
Exhibit 99.1
| J.P. Morgan Healthcare
Conference
January 9, 2024
Jeff Simmons
President & Chief Executive Officer |
| © 2024 Elanco or its affiliates
This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934 (Exchange Act), including, without limitation, our long-term revenue and earnings growth expectations, reduction of debt and leverage, expectations regarding product launches
and related regulatory proceedings, and our industry and our operations, performance, and financial condition. Forward-looking statements are based on our current expectations and
assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent
uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking
statements.
Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national, or global political, economic, business,
competitive, market, and regulatory conditions, including but not limited to the following: heightened competition, including from generics; the impact of disruptive innovations and
advances in veterinary medical practices, animal health technologies and alternatives to animal-derived protein; changes in regulatory restrictions on the use of antibiotics in farm
animals; our ability to implement our business strategies or achieve targeted cost efficiencies and gross margin improvements; consolidation of our customers and distributors; an
outbreak of infectious disease carried by farm animals; the impact on our operations, the supply chain, customer demand, and our liquidity as a result of the COVID-19 global health
pandemic; the potential impact on our business and global economic conditions resulting from the conflict involving Russia and Ukraine; the success of our R&D and licensing efforts;
misuse, off-label or counterfeiting use of our products; unanticipated safety, quality or efficacy concerns and the impact of identified concerns associated with our products; fluctuations
in our business results due to seasonality and other factors; the impact of weather conditions and the availability of natural resources; risks related to the modification of foreign trade
policy; risks related to currency rate fluctuations; our dependence on the success of our top products; the impact of customer exposure to rising costs and reduced customer income;
the lack of availability or significant increases in the cost of raw materials; use of alternative distribution channels and the impact of increased or decreased sales to our channel
distributors resulting in fluctuation in our revenues; risks related to the write down of goodwill or identifiable intangible assets; risks related to the evaluation of animals; manufacturing
problems and capacity imbalances; the impact of litigation, regulatory investigations, and other legal matters, including the risk to our reputation and the risk that our insurance policies
may be insufficient to protect us from the impact of such matters; actions by regulatory bodies, including as a result of their interpretation of studies on product safety; risks related to tax
expense or exposure; risks related to environmental, health and safety laws and regulations; risks related to our presence in foreign markets; challenges to our intellectual property
rights or our alleged violation of rights of others; our dependence on sophisticated information technology and infrastructure and the impact of breaches of our information technology
systems; the impact of increased regulation or decreased financial support related to farm animals; adverse effects of labor disputes, strikes, work stoppages, and the loss of key
personnel or highly skilled employees; risks related to underfunded pension plan liabilities; our ability to complete acquisitions and successfully integrate the businesses we acquire, the
effect of our substantial indebtedness on our business, including restrictions in our debt agreements that will limit our operating flexibility; and risks related to certain governance
provisions in our constituent documents.
For additional information about the factors that could cause actual results to differ materially from forward-looking statements, please see our latest Form 10-K and subsequent Form
10-Qs filed with the Securities and Exchange Commission. We undertake no duty to update forward-looking statements.
Forward-looking statements
2 |
| Today’s
Key
Messages
Attractive industry backdrop for Elanco – a global, independent Animal
Health leader
Our Innovation, Portfolio, Productivity (IPP) strategy designed to
deliver value to all stakeholders, rooted in a deep focus on the customer
Q3 2023 return to topline growth driven by accelerating innovation
contribution, stabilizing core volumes and price growth
Momentum going into 2024, with expected constant currency
revenue growth driven by existing portfolio
Elanco well positioned with next era of innovation and growth to drive
meaningful long-term value creation
A Leader in the Animal Health Industry
3
J.P. Morgan Healthcare Conference | January 2024
Well-positioned to deliver meaningful long-term value |
| 4
Farm Animal
$23B Global Industry1
Protein demand growth globally
driven by GDP growth,
expanding protein diets, and
efficient trade
Producers focused on
food safety, disease
prevention and productivity
Livestock sustainability
expected to create the next
industry opportunity
Animal Health:
Attractive, Growing Markets with Positive Long-Term Tailwinds
1
Industry figures represent Elanco analysis of 2023 market data and internal estimates for animal health medicines and vaccines.
Industry Success Factors: Broad Portfolios, Innovation, Global Reach, Value-added Capabilities
Pet Health
$15B Global Industry1
Pet ownership and
“humanization” of pets
a continued tailwind globally
Increased compliance
and convenience
expected to drive growth
Innovation and differentiation
to create value
across the value chain
J.P. Morgan Healthcare Conference | January 2024 |
| 5
Elanco: An Independent, Global Animal Health Leader
1Non-GAAP financial measure. See Appendix to this presentation for more information, including GAAP to non-GAAP reconciliations.
2 Potential blockbusters expected in 2024 are Bovaer, Credelio Quattro, and Zenrelia
Note: Revenue breakdowns based on the midpoint of 2023 full year guidance, as provided in the Company’s Q3 2023 earnings presentation issued on November 8, 2023.
$4.38 B
Revenue
$0.91
Adj. EPS1
$983 M
Adj. EBITDA1
Key Financial Metrics
2023 Guidance Midpoint (as of November 8, 2023)
Actions and Progress Building Momentum
Completed independent company stand up
Intentional portfolio shift towards high margin Pet Health
Multiple decisive actions and restructurings to execute on
synergy capture and productivity
Bayer systems integration completed in 2023
Expect 6 potential blockbusters in market by 2025, with 3 on a
path to H1 2024 approval2
Diverse, Global Portfolio
Balanced Across Geography and Species
Revenue Category
by Geography
19%
35%
17%
29%
Pet Health
Farm Animal
International
U.S.
J.P. Morgan Healthcare Conference | January 2024
Revenue
by Species
48%
22%
17%
9%
4%
Pet Health
Cattle
Poultry
Swine
Percentages may not add due to rounding.
Aqua |
| © 2024 Elanco or its affiliates
n
I
novation
Portfolio
Productivity
Customer
Veterinarian
Farmer
Pet Owner
IPP:
Innovation,
Portfolio,
Productivity
Elanco’s Strategy
to Deliver Value to
All Stakeholders,
Rooted in a Deep
Focus on the
Customer
Deliver consistent, high-impact Innovation
• $600-$700 million annual new revenue from Innovation expected by 20251
• Target first-in-class, differentiation and big market spaces
• Focus on maximizing life cycle management and refilling early-stage pipeline
Optimize our diverse Portfolio to grow market share
• Leverage deep customer relationships, expanding portfolio and improved mix
• Invest in strategic commercial capabilities – sales force, digital, pricing, data -
preparing for historic innovation launch window
• Drive geographic and channel expansion to reach more of the world’s animals
Improve Productivity & cash flow
• Company-wide productivity agenda driving margin expansion since IPO
• Improve cash conversion to fund reinvestment and debt paydown
• Significant ERP transformation, driving efficiency and
enabling future business optionality
1Expected innovation revenue is from products launched from 2021 to 2025 and
does not include the expected impact of cannibalization on the base portfolio.
J.P. Morgan Healthcare Conference | January 2024
6 |
| 7
Focused on Delivering Consistent, High Impact Innovation
With three clear parallel priorities for the R&D organization
Life Cycle
Management
Extending the life and value of our existing
brands with targeted life cycle management
(LCM) is core to Elanco’s value proposition to
customers and contributes to a stabilizing base.
LCM Opportunity Examples
Label claim extensions
Geographic expansions
Species expansions
Presentation and delivery
Packaging and safety
Regulatory registration renewals
Refill Pipeline
with Next Wave
To deliver consistent, high-impact innovation
over time, we are refilling our early-stage
pipeline with the next wave of innovation –
focused on first and best in class opportunities.
Targeted Areas of Focus
Concentrated efforts in next generation:
Pet parasiticides
Pet dermatology
Pet pain
Livestock sustainability
Leveraging existing platforms (e.g. MAb)
and emerging spaces of unmet need
Late-Stage
Pipeline
Focus on first-in-class or differentiated
late-stage potential blockbusters in high-value pet health market and pioneering new
frontier markets with livestock sustainability.
nI novation
Portfolio
Productivity
Customer
6
potential blockbuster products
expected in U.S. market by
2025
J.P. Morgan Healthcare Conference | January 2024 |
| 8
nI novation
Portfolio
Productivity
Customer
1Blockbuster refers to product with annual revenue above $100 million. 2Expected submission and launch timing is based on internal estimates and could change as programs evolve.
3Potential approval timing is subject to regulatory agency outcomes. 4
Industry figures represent Elanco analysis of 2023 market data and internal estimates, except for Bovaer which is
based only on internal estimates for market potential. Note that Elanco only has U.S. rights for Bovaer. 5Expected trade name upon approval. 6Short acting.
Blockbuster-Potential Products
Regulatory
Agency Species
Product
Development
Initial
Submission2 Approval3 Launch2 Global Market4 Commentary
Experior
Ammonia Reduction FDA (Rx) New Space First-in-class
Canine Parvovirus
Monoclonal Antibody
(CPMA)
USDA (Rx) New Space First-in-class;
Monoclonal AB
Credelio Quattro™5
Endecto Parasiticide FDA (Rx) H1 2024 $6.5 billion Differentiated
Zenrelia™5
Dermatology FDA (Rx) H1 2024 $1.5 billion Differentiated
Bovaer®
5
Methane Reduction FDA H1 2024 $1 to $2 billion First-in-class
IL-31 SA6 MAb
Dermatology USDA (Rx) 2025 $1.5 billion Differentiated;
Monoclonal AB
Q4 2022
Q4 2022
Q4 2022
Progress in 2023
Innovation Launches Expected to Fuel Return to Growth
Q1 2023
6 Blockbuster-Potential1 Products, Complemented by Portfolio Enhancing Assets
Q2 2023 conditional Q3 2023
J.P. Morgan Healthcare Conference | January 2024 |
| © 2024 Elanco or its affiliates
Vision
Helping pets
live longer,
healthier, more
active lives
Where We Play
J.P. Morgan Healthcare Conference | January 2024
1 US only. 2Expected trade name upon approval.
Global Pet Health
Strategic Framework
FAMILY
FAMILY
ZENRELIATM 2
IL-31 MAb
Parasiticides Dermatology Pain & Other
Therapeutics
Vaccines1
`
Next Wave of Innovation
9 |
| © 2024 Elanco or its affiliates
Key Enablers
Innovation Address unmet needs and expand portfolio
Share of Voice Increase product awareness with our customers
Physical Availability Maximize access to our products
Price Execution Optimize value based on willingness to pay
1 US only.
J.P. Morgan Healthcare Conference | January 2024
Global Pet Health
Strategic Framework
Vision
Helping pets
live longer,
healthier, more
active lives
Where We Play
Parasiticides Dermatology Pain & Other
Therapeutics
Vaccines1
10 |
| © 2024 Elanco or its affiliates
Global Farm Animal
Strategic Framework
Vision
Helping
farmers improve
animal health
and wellbeing,
and raise
livestock more
sustainably
1Expected trade name upon approval.
J.P. Morgan Healthcare Conference | January 2024
Where We Play
Efficiency &
Performance
Disease
Prevention &
Treatment
Food Safety Sustainability
BOVAER®1
Next Wave of Innovation
11 |
| © 2024 Elanco or its affiliates
Global Farm Animal
Strategic Framework
Vision
Helping
farmers improve
animal health
and wellbeing,
and raise
livestock more
sustainably
J.P. Morgan Healthcare Conference | January 2024
Where We Play
Efficiency &
Performance
Disease
Prevention &
Treatment
Food Safety Sustainability
Portfolio Comprehensive, complementary product offerings
Value Beyond Product Data and analytics to drive improved outcomes
Innovation Solutions to producers’ greatest challenges
Price Execution Optimize value based on willingness to pay
Key Enablers
12 |
| 13
Improve Productivity and Cash Flow
IPO to 2023
Improving cash conversion through
• Reduced project expense
• Continued productivity improvements
• Improvement in NWC, led by inventory
• New high-margin blockbuster innovation
Key Proof Points
Expanded Margins ~$400 million
of manufacturing productivity achieved
from 2018 through 2023
Reduced Footprint2
from 9 to 6 R&D sites;
20 to 18 Internal manufacturing sites
Introduced Elanco Cash Earnings (ECE) to
incentivize annual improvement in after-tax
returns in excess of cost of capital
Capital Allocation
Priorities
Actions and progress to support investment in the business and de-leveraging
Improving margin through
• Optimizing organization & footprint
• Enhanced ownership mentality
• API1 sourcing improvements
• SKU Rationalization
2024 and Beyond
Near Term Expectations
Project Cash Costs: ~$1 billion since IPO;
reduces to <$20 million annually in 2024+
~$380 million of cumulative Adj. EBITDA
Synergies; expected at $400 million+ in 2024
as ERP consolidation completion is realized
Future innovation is expected to be
accretive to corporate margin over time
Invest in the Business
R&D, Launch Readiness,
Commercial Excellence
Debt Pay Down
Primary use of
Free Cash Flow
J.P. Morgan Healthcare Conference | January 2024
nI novation
Portfolio
Productivity
Customer
1Active pharmaceutical ingredient.
2Represents data from initial Bayer animal health acquisition footprint in August 2020 compared to footprint at year-end 2023. R&D sites refers to global R&D sites. |
| H2 2023 Marks Expected Return to Topline Growth
Revenue
Year-over-year CC1 Change
Innovation Ramp
Price Growth
Improved Supply
Improved EU Pet Retail
Environment
Growth in Poultry
1CC = Constant Currency, representing the growth rate excluding the impact of foreign exchange rates.
2Based on company’s Q3 2023 results and Q4 2023 guidance issued on November 8, 2023.
Drivers of Growth Inflection:
2022 H1
Actual
2022 H2
Actual
2023 H1
Actual
2023 H2
Expected
0%
2023: Flat to 1% Growth 2022: 3% Decline 2
(1)%
(5)%
(1)%
+2% to +4%2
Stabilizing Base
Business
Innovation and a Stabilizing Base Business Drives Inflection
nI novation
Portfolio
Productivity
Customer
J.P. Morgan Healthcare Conference | January 2024
14 |
| 1Expect revenue growth in constant currency, representing the growth rate excluding the impact of foreign exchange rates, driven by existing portfolio is achievable before new blockbuster-potential launches.
Tailwinds
Existing innovation ramp and 3 new blockbuster-potential launches
Expanded physical availability in Pet retail
Enhanced share of voice in U.S. Pet vet
Improved EU pet retail market impacting H1
Growth in poultry, aqua & price
Reduced project cash costs
Expected Outcomes Deliver High
Impact Innovation
Launch New Products
with Excellence
Improve OCF
and de-lever
Grow
Revenue
Headwinds
Competition in U.S. Pet Health vet clinic business
Farm Animal generics and U.S. cattle numbers
Gross margin headwind related to internal inventory management
Investments to support launches in sales, marketing, and capex
U.S. dollar strength
Early Considerations for 2024, Continued Revenue Growth1 nI novation
Portfolio
Productivity
Customer
J.P. Morgan Healthcare Conference | January 2024
15 |
| Attractive, Growing Markets
Progressing a Valuable
Late-Stage Pipeline
Disciplined Delivery,
Infrastructure Optimization
Improving Financial Profile
An Established Market Leader
~$38B global industry across Pet Health ($15B) and Farm Animal ($23B)
with consistent mid-single digit growth driven by durable trends
A top-tier global player with portfolio diversity in 6 core species and
leadership in OTC Pet parasiticides, Poultry, and Farm Animal Sustainability
Path to 6 potential blockbuster products in major market spaces
contributing toward an incremental $600-$700 million in Revenue by 2025
Reduced costs and expanded margins amidst macro challenges,
with infrastructure optimization to support growth from innovation
Moving past stand up and integration cash costs,
with focus on reinvestment in business and debt paydown
Elanco:
A Compelling Long-Term Value Proposition
J.P. Morgan Healthcare Conference | January 2024
16 |
| Guidance and GAAP reported to
non-GAAP adjusted reconciliations
Appendix
17 |
| Full Year 2023
Financial
Guidance1
$ millions, except
per share values
2023
Revenue $4,360 - $4,400
Reported Net Loss $(1,204) - $(1,174)
Adjusted EBITDA2 $965 - $1,000
Reported Diluted EPS $(2.43) - $(2.37)
Adjusted Diluted EPS2 $0.88 - $0.94
1Represents 2023 full year guidance, as provided in the Company’s Q3 2023 earnings presentation issued on November 8, 2023.
2Non-GAAP financial measure. See slides 19 and 20 for the GAAP to non-GAAP reconciliations.
18 |
| Full Year 2023
Reported Loss per Share $(2.43) - $(2.37)
Amortization of Intangible Assets Approx. $1.11
Asset Impairment, Restructuring, and Other Special Charges2 $0.19 - $0.21
Goodwill Impairment3 $2.11
Other Expenses, Net Approx. $0.06
Subtotal $3.47 - $3.49
Tax Impact of Adjustments $(0.18) - $(0.16)
Total Adjustments to Earnings per Share Approx. $3.31
Adjusted Earnings per Share4 $0.88 - $0.94
EPS Guidance
Reconciliation1
Note: Numbers may not add due to rounding.
1Represents 2023 full year guidance, as provided in the Company’s Q3 2023 earnings presentation issued on November 8, 2023.
2Asset impairment, restructuring, and other special charges adjustments are related to integration efforts, including the acquisition of the animal health business of Bayer.
3Current guidance does not assume any further impairment beyond the third quarter charge.
4Adjusted EPS is calculated as the sum of reported EPS and total adjustments to EPS.
19 |
| Full Year 2023
$ millions
Reported Net Loss $(1,204) - $(1,174)
Net Interest Expense Approx. $280
Income Tax Provision $27 - $44
Depreciation and Amortization Approx. $695
EBITDA $(199) - $(154)
Non-GAAP Adjustments
Cost of Sales Approx. $2
Asset Impairment, Restructuring, and Other Special Charges Approx. $100
Goodwill Impairment2 $1,042
Accelerated Depreciation and Other Special Charges Approx. $(10)
Other Expense (Income), Net Approx. $28
Adjusted EBITDA $965 - $1,000
Adjusted EBITDA Margin 22.1% - 22.7%
EBITDA
Guidance
Reconciliation1
Note: Numbers may not add due to rounding
1Represents 2023 full year guidance, as provided in the Company’s Q3 2023 earnings presentation issued on November 8, 2023.
2Guidance does not assume any further impairment beyond the third quarter charge
20 |
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