UNITED STATES
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FORM
CURRENT REPORT
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Item 2.02 | Results of Operations and Financial Condition. |
In connection with its participation at the 40th Annual J.P. Morgan Health Care Conference (the “JPM Conference”) to be held from January 10-13, 2022, Elanco Animal Health Incorporated (the “Company”) will report that it continues to expect to deliver results within its financial guidance ranges for the full year and fourth quarter of 2021, which were previously provided by the Company on November 5, 2021 and November 30, 2021.
This is based on management’s initial analysis of operations for the full year and fourth quarter of 2021. However, the Company is still in the process of completing the closing procedures for its financial results for such periods and the related financial audit. The Company expects to issue full financial results for the full year and fourth quarter of 2021 in February 2022.
Item 7.01 Regulation FD Disclosure.
On January 11, 2022, the Company will present at the JPM Conference. A copy of the Company’s presentation is furnished as Exhibit 99.1.
In addition to the information about the Company’s 2021 financial guidance set forth in Item 2.02 above, key points from the presentation include:
· | In 2022, the Company expects to deliver continued revenue growth and double-digit percent adjusted EBITDA and adjusted EPS growth. The Company plans to provide 2022 financial guidance in connection with its fourth quarter and full year 2021 earnings release in February 2022. |
· | In November 2021, the Company announced a restructuring that, once fully realized, should deliver approximately $70 million in annualized savings. Approximately $45 million of those savings are expected to be incremental to the $300 million value capture commitment the Company made in connection with its acquisition of Bayer Animal Health in 2020. |
· | In 2022, the Company expects to obtain approval, and intends to launch, at least seven new products in major markets. These portfolio-enhancing products are expected to be concentrated in pet health and are expected to include products in the following areas: pain, parvovirus, vaccines, and over-the-counter (OTC) parasiticides. |
· | The Company is making progress against the development milestones related to the potential pet health blockbuster products in its portfolio. |
· | The Company continues to believe it will deliver annualized innovation-related sales of $600 million to $700 million by 2025, as well as achieve its previously communicated long-term adjusted gross margin, adjusted EBITDA margin and net leverage targets. |
· | Finally, as part of its short-term compensation program, the Company is introducing an EVA-like metric that focuses on improving returns on after-tax cash in excess of cost of capital, which has been shown to correlate with total shareholder return. |
The information contained in the accompanying Exhibit 99.1 is being furnished pursuant to Item 7.01 of Form 8-K. Neither the information set forth in Item 2.02 above, or the information furnished pursuant to this Item 7.01, shall be deemed to be “filed” for purposes of Section 18 of the Exchange Act, nor 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 or the Exchange Act, whether made before or after the date hereof, except as otherwise expressly stated in such filing.
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 Company’s financial results and future performance, expected cost savings from the Company’s restructuring program, and future product launches and associated revenue. These forward-looking statements are based on the Company’s current expectations and assumptions regarding, among other things, the Company’s operations, performance, and financial condition, and are subject to change. The Company’s current expectations are also subject to the completion of the Company’s financial close process and financial audit for the full year 2021 and are also subject to change. 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 | Investor Presentation of Elanco Animal Health Incorporated. | |
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: January 10, 2022 | By: | /s/ Todd Young |
Name: Todd Young | ||
Title: Executive Vice President and Chief Financial Officer |
Exhibit 99.1
January 11, 2022 J.P. Morgan Healthcare Conference Jeff Simmons President & Chief Executive Officer
This presentation contains forward - looking statements within the meaning of Section 27A of the Securities Act of 1933 and Sectio n 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 conditio n . Forward - looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward - loo king 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 regi onal, national, or global political, economic, business, competitive, market, and regulatory conditions, including but not limited to the following: heightened competition, in cluding from generics; the impact of disruptive innovations and advances in veterinary medical practices, animal health technologies and alternatives to animal - deriv ed protein; changes in regulatory restrictions on the use of antibiotics in farm animals; our ability to implement our business strategies or achieve targeted cos t efficiencies and gross margin improvements; consolidation of our customers and distributors; an outbreak of infectious disease carried by farm animals; the im pact on our operations, the supply chain, customer demand, and our liquidity as a result of the COVID - 19 global health pandemic; the success of our research and developme nt (R&D) and licensing efforts; misuse, off - label or counterfeiting use of our products; unanticipated safety, quality or efficacy concerns and the impact of id entified concerns associated with our products; the impact of weather conditions and the availability of natural resources; use of alternative distribution channel s a nd the impact of increased or decreased sales to our channel distributors , resulting in fluctuation in our revenues; manufacturing problems and capacity imbalances; challenges to our intellectual property rights or our alleged violation of rights of others; risks related to our presence in foreign markets; breaches of our information tech nology systems; our ability to complete acquisitions and successfully integrate the businesses we acquire, including Kindred BioSciences , Inc. and the animal health business of Bayer AG (Bayer Animal Health); the terms, timing or structure of any separation of the microbiome R&D platform, including whether it will be consummat ed at all, and whether the operational and strategic benefits of such transaction can be achieved, including whether the uncertainty of announcing the separation initi ative will have adverse impacts on the employees, customers and suppliers related to the platform; the effect of our substantial indebtedness on our business; the unce rtainties inherent in research relating to product safety and additional analyses of existing safety data; actions by regulatory bodies, including as a result of their int erpretation of studies on product safety; unfavorable publicity resulting from media reports on our products; public acceptance of our products; fluctuations in our bu sin ess results due to seasonality and other factors; and the impact of litigation, regulatory investigations, and other legal matters. For additional information about the factors that could cause actual results to differ materially from forward - looking statement s, 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
3 Today’s Takeaways Delivering on 2020 Investor Day commitments Four quarters of outperformance since 2020 Investor Day Strategic actions further enabling progress and delivery Durable, global portfolio expected to drive continued revenue growth in 2022 Expect double - digit percent adjusted EBITDA and adjusted EPS growth in 2022 Building A Leader In The Growing Animal Health Industry
Animal Health Market Trends Leading into 2022 Pet Health $14B Industry COVID increased pet ownership globally, trends slowing but persisting Pet owner experience has improved, led by omnichannel distribution, vet clinic experience, and hybrid work Average spend per vet visit driving growth Compliance levels expected to remain elevated vs historical averages Farm Animal $22B Industry Protein demand continues to grow globally driven by increasing GDPs and expanding protein diets Poultry growth momentum expected to extend into 2022 Environmental sustainability creating next era of industry opportunity Labor, inflation and trade challenges persist Note: Industry figures represent Elanco market analysis for 2022 based on Vetnonsis , Animal Pharm and internal estimates. 4 I ndustry Success Factors: Broad Portfolios, Innovation, Global Reach, Value - added Capabilities
5 Building a Leader Positioned to Deliver Increase Value Integrating Bayer Full - year 2021 guidance exceeds Investor Day expectations Increased speed, productivity and higher value late - stage pipeline 4 Revenue Adj. EBITDA Adj. EPS Quarters of exceeding expectations for : *Estimate based on mid - point of 2021 guidance range for revenue of $4,730 million to $4,770 million as provided in the Q3 2021 e arnings release issued on November 5, 2021. REVENUE Long - term Algorithm from 2020 Investor Day Scale Mix Global reach Value - based Capabilities Building a Leader Completed independent standup + + + + Consistently Growing & Delivering + + + Driving Continued Momentum toward Commitments Expect continued durable, global revenue growth, pipeline progression, and double - digit profitability aligned with Investor Day Strengthening through Strategic Actions + Simplified structure Streamlined Manufacturing Focused and increased pipeline value Increased synergies to $345 Million by 2023 + + +
6 A Global, Balanced Portfolio to Drive Growth Note: Percentages derived from internal estimates and the mid - point of 2021 guidance range for revenue of $4,730 million to $4,770 million as provided in the Q3 2021 earnings release issued on November 5, 2021, excluding Contract Manufacturing and may not add due to rounding. 56% 44% 21% 34% 15% 29% 50% 21% 15% 10% 3% Balanced global revenue base Diverse product portfolio enables durable revenue performance Significant pet health business; Enhanced cattle portfolio; Poultry leadership Geography: More Global Revenue Category: More Diverse Species: More Balanced Mix U.S. International Farm Animal Dogs & Cats Cattle Poultry Swine Aqua Pet Health Pet Health Farm Animal U.S. International
7 Growth Profitability Results ~3% - 4% Average Annual Revenue Growth (1 )(2) Double - Digit Annual Adjusted EBITDA (2) Growth Progressing Toward Long - Term Targets of 60 % Adjusted Gross Margin (2) and 31% Adjusted EBITDA (2) Margin Double - Digit Annual Adjusted EPS (2) Growth Innovation and Focus B rands L eading G rowth Progressing Toward Net Leverage <3x Long - Term Algorithm for Accelerated Value Creation Remains, Progressing Toward Targets (1) Refers to Constant Exchange Rate (CER) growth, representing the growth rate excluding the impact of foreign exchange rates. (2) Non - GAAP financial measure. See Appendix for more information.
Since Investor Day 2020 Four Consecutive Quarters of Outperformance 8 $1,055 $1,160 $1,240 $1,089 $1,140 $1,242 $1,279 $1,131 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Expectations Actual $150 $238 $263 $208 $176 $343 $291 $211 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Expectations Actual Revenue Adj. EBITDA $ millions (1) Expectations based on the mid - point of the company’s quarterly guidance ranges except for Q1 2021 Adjusted EBITDA, which is analyst consensus derived from Factset financial data and analytics. The company did not provide quarterly guidance for Adjusted EBITDA in Q1 2021. (1) (1)
9 November 2021 Guidance Expected to Beat Investor Day Expectations $4,520 - $4,600 $4,730 - $4,770 3% 7% 2% 7% $4,240 $4,280 $4,320 $4,360 $4,400 $4,440 $4,480 $4,520 $4,560 $4,600 $4,640 $4,680 $4,720 $4,760 $4,800 Investor Day November Guidance Revenue Year-Over-Year Growth +$190M 2021 Revenue Guidance $940 - $1,000 $1,035 - $1,075 21% - 22% 22% - 22.5% 20% 25% $800 $840 $880 $920 $960 $1,000 $1,040 $1,080 Investor Day November Guidance Adj. EBITDA Adj. EBITDA Margin +$85M 2021 Adj. EBITDA (2) Guidance $0.83 - $0.95 $0.97 - $1.03 2% 7% $1 Investor Day November Guidance +11c 2021 Adj. EPS (2) Guidance $ Millions Except Per Share Data Dec 2020 Dec 2020 Dec 2020 (1) Refers to year - over - year reported revenue growth, to the midpoint of November guidance, on a pro forma combined company basi s (6% pro forma revenue growth expected at constant currency). The pro forma combined company figures represent estimates based on the historical records of Bayer and Elanco; however, due to certa in data limitations, including foreign exchange rates, these numbers may have some non - material differences from actuals. 2020 pro forma combined company numbers represent a good faith summary to provide be tter financial context about historical performance. (2) Non - GAAP financial measure. See Appendix for more information. (1)
Strategic Actions to Strengthen Delivery Since Investor Day Completed independent company standup fully separating from Lilly systems Progressed and increased pipeline launched 8 new products in 2021 in major markets , progressed blockbusters, added KindredBio assets Simplified structure and optimized manufacturing footprint, while maintaining stability in critical areas driving value Introduced company - wide EVA - like compensation metric to further align employee and shareholder interests 10 Strengthened Board governance and engagement including direct shareholder representation and enhanced committee oversight Issued first ESG summary, assessing feedback from ESG roadshow, actively integrating sustainability solutions as value drivers for customers
11 Growth Concentration Progression Added scale with Bayer Animal Health and KindredBio Enhanced monoclonal antibody capabilities Focused on delivery of late - stage pet health potential blockbusters in large markets Simplified structure and optimized site network Launched 8 new products in 2021; ~7+ portfolio enhancing launches expected in 2022 (e.g., pain, parvo, para OTC, vaccine) Development milestones for pet health blockbusters are progressing R&D Organization Well - Positioned to Deliver Innovation Pipeline Remain Committed to Deliver $600 to $700 million of Innovation Revenue by 2025
Shifting R&D Investment to Pet Health and Large Markets Focused on Delivering Late - Stage Potential Blockbusters NME 66% LCM 34% Percentage Investment in PH increased from 57% at Investor Day from the proposed microbiome carve - out and reprioritization of resources Pet Health 73% Farm Animal 27% Variable R&D Investment Dollars (1) By R&D phase By Species By R&D Project Type Research 12% Development 81% Submission 7% Investment concentrated in Development phase Early - stage research phase focused on re - filling pipeline and next generation solutions 12 Dedicated investment in NME’s with high unmet need and market potential Intentional LCM investment to grow brands (1) Variable investment dollars shown as a percent of total expected 2022 R&D project spend. NME = New Molecular Entity; LCM = Life Cycle Management
Focus Significant Brands Accretive to Growth Core Portfolio Value Drivers Defend Material Brands, Highly Profitable Maximizing Value Of Current Portfolio Innovation Internal Pipeline External Innovation Enabled by Overall Pricing Digital Ecosystem Omnichannel Leadership Geographic Focus 2% - 3% 2% - 3% 0% - 1% (1)% - (2)% ~3% - 4% Expected Long - Term Contribution to Average Annual Total Revenue Growth LT Algorithm: ~3% - 4% Average Annual Revenue Growth 2022: Continued Growth Driven by Durable, Global Portfolio 13 Launch Excellence Revenue growth refers to Constant Exchange Rate (CER ) growth, representing the growth rate excluding the impact of foreign exchange rates.
IPP: Continuously Strengthened & Expanded Strategy Concentrated in Highest Potential Areas Shift of resources into Pet Health, focusing on markets of significance Expect to deliver $600 to $700 million in innovation sales by 2025 Intentional pipeline mix to balance blockbusters with portfolio solutions Complementary external innovation as partner of choice Unlocking Value Adjusted EBITDA synergies of $345M expected by 2023 Confidence in debt paydown and path to <3x leverage by Q1 2024 Adj. gross margin (1) 60% and adj. EBITDA margin (1) 31% targets intact Focused for Growth and Leadership Launch and Focus Brands to lead growth Execution on enablers remains key to portfolio strategy Pet Health: broad, global Para portfolio; Pain leader; significant Derm pipeline Farm Animal: leader in poultry and cattle , growing leadership in sustainability 14 Customer Veterinarian Farmer Pet Owner (1) Non - GAAP financial measure. See Appendix to this presentation for more information.
15 Today’s Takeaways Delivering on 2020 Investor Day commitments Four quarters of outperformance since 2020 Investor Day Strategic actions further enabling progress and delivery Durable, global portfolio expected to drive continued revenue growth in 2022 Expect double - digit percent adjusted EBITDA and adjusted EPS growth in 2022 Building A Leader In The Growing Animal Health Industry
Food and Companionship Enriching Life 16
Reference slides and GAAP reported to non - GAAP adjusted reconciliations Appendix 17
This presentation includes U.S. GAAP and non - GAAP financial measures, and a reconciliation between these measures is available in this appendix. We believe these non - GAAP financial measures are useful to investors because they provide greater transparency regarding our operating performance. Non - GAAP financial measures used in this presentation include adjusted EBITDA and adjusted EPS. These non - GAAP measures are not, and should not be viewed as, substitutes for U.S. GAAP reported measures. We encourage investors to review our financial statements in their entirety and caution investors to use U.S. GAAP measures as the primary means of evaluating our performance, value and prospects for the future, and non - GAAP measures as supplemental measures. Our long - term algorithm for accelerated value creation are non - GAAP measures we expect to achieve in future periods. The revenue growth measure assumes constant currencies. Reconciliations for the forward - looking annual adjusted gross margin and the adjusted EBITDA margin targets, as well as the adjusted EPS growth target, to their most directly comparable GAAP measures have not been provided as permitted by Item 10(e)(1)( i )(B) of Regulation S - K. These non - GAAP measures generally exclude unusual or non - recurring items that investors may consider to be unrelated to our long - term operations to provide greater transparency regarding our operating performance. Reconciliations of such measures would require unreasonable efforts at this time to estimate and quantify with a reasonable degree of certainty various necessary GAAP components. Use of non - GAAP financial measures 18
Full Year 2021 19 EPS Guidance Reconciliation November Update Note: Numbers may not add due to rounding (1) Cost of sales adjustment is related to the amortization of inventory fair value adjustments recorded from the acquisition of Bay er Animal Health (2) Asset impairment, restructuring, and other special charges adjustments are related to integration efforts and external costs rel ated to the acquisition of businesses, including the acquisition of the animal health business of Bayer, and charges primarily related to independent stand - up costs and other related activities, including se verance (3) Adjusted EPS is calculated as the sum of reported EPS and total adjustments to EPS
Full Year 2021 $ millions 20 Note: Numbers may not add due to rounding EBITDA Guidance Reconciliation November Update
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