The Sustainability Accounting Standards Board (SASB) provides a collection of industry-specific standards to help measure and communicate performance on environmental, social and corporate governance topics. This report includes responses for the SASB Biotechnology and Pharmaceuticals standard. Select indicators (noted in the tables below) are not applicable to animal health companies, such as Elanco.
Inclusion of information in this report should not be construed as a characterization of the financial materiality or impact of that information. Please see our Corporate Annual Report or Form 10-K for the year ended December 31, 2022 and other publicly-filed documents available on the Elanco Investor Relations website.
|Number of Patients Treated||Number of Patients Treated||HC-BP-000.A||Not applicable for animal health.|
|Number of drugs (1) in portfolio and (2) in research and development (Phases 1-3)||HC-BP-000.B|
As disclosed in our Form 10-K, we offer a diverse portfolio of approximately 200 brands to veterinarians, farm animal producers, and pet owners.
Phases 1-3 are not applicable for animal health; however, our R&D pipeline consists of over 170 active projects across species and platforms.
|Safety of Clinical Trial Participants||Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials||HC-BP-210a.1|
Key features of our approach to research animal welfare include:
All clinical research is appropriately monitored by scientific staff at Elanco. Prior to contracting and as a part of due diligence, CROs are vetted by our animal welfare, quality assurance organizations, and legal teams, and undergo a third-party risk assessment, as appropriate.
Monetary Incentives Used by CROs
Compensation for each study is allocated on an individual basis aligned with milestones reached or work executed.
Clinical Trials Terminated due to Failure to Follow Good Clinical
In 2022, no studies were terminated due to inadequate clinical practices. Multiple studies were terminated due to project-specific reasons. In the event a trial is terminated, a final study report is always issued and archived.
We conduct annual internal audits for all Elanco sites and audit partner research facilities at least once every three years. We are also subject to external audits by accreditation organizations and government regulators at prescribed intervals.
More information can be found in the Elanco Animal Welfare Issue Brief.
|Number of FDA Inspections related to clinical trial management and pharmacovigilance that resulted in (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI)||HC-BP-210a.2||In 2022, one CRO conducting an Elanco-sponsored study received a Form 483 for minor observations. The findings had no influence on the quality and integrity of the study data. (Note: VAI and OAI procedures do not apply to animal health trials or pharmacovigilance reporting.)|
|Total amount of monetary losses as a result of legal proceedings associated with clinical trials in developing countries||HC-BP-210a.3||None reported. If applicable, monetary losses as a result of legal proceedings associated with clinical trials would be included in our Annual Report on Form 10-K|
|Access to Medicines|
Description of actions and initiatives to promote access to health care products for priority diseases and in priority countries as defined by the Access to Medicine Index
The Access to Medicines Index applies to human healthcare companies and is not relevant to Elanco as an animal health company.
Elanco’s East Africa Growth Accelerator (EAGA) initiative was active between 2017 and early 2022 and helped improve the productivity of small-scale livestock producers in Tanzania, Kenya and Uganda. Through the initiative, Elanco registered and distributed high-quality, affordable veterinary products in adjusted small pack sizes and facilitated access to feed additives and education to help prevent and combat livestock disease. In 2022, we compiled the final outcomes from this initiative. Post-project research indicates more than 60% of the farmers demonstrated behavioral change, implementing recommended practices for better livestock management. We continue to extend the impact of EAGA by supporting small-scale producers in the region through our commercial sales channels.
Additionally, the Managing Animal Health and Acaricides for a Better Africa (MAHABA) initiative is a collaboration between Elanco and GALVmed (the Global Alliance for Livestock Veterinary Medicine), with support from the Bill & Melinda Gates Foundation – to aid small-scale beef and dairy producers in Uganda and small-scale cattle and poultry producers in Nigeria. Livestock farming is a significant source of food and income in these countries. At the same time, ticks and tick-borne diseases represent a significant economic burden to cattle farming and, overall, the development of the livestock sector in sub-Saharan Africa. Direct and indirect effects of tick infestations negatively impact animal health and output, farmer productivity and the economic stability of small-scale livestock producers. Treatment failures and tick resistance are prevalent in the region, due to a lack of education and resources that lead to inappropriate selection of chemical classes and application of acaricides.
Through the MAHABA initiative, we seek to equip small-scale producers in Uganda and Nigeria with quality acaricides and education, to help them realize significant livestock productivity gains by better managing ticks and the impact of tick-borne-disease. MAHABA expands the geographic reach of products made available through EAGA, to enhance the productivity of Nigerian cattle and poultry producers with quality acaricides, vaccines, medicines and feed additives.
|List of products on the WHO List of Prequalified Medicinal Product as part of its Prequalification of Medicines Programme (PQP)||HC-BP-240a.2||None of our products are on the WHO List of Prequalified Medicinal Products.|
|Affordability and Pricing||Number of settlements of Abbreviated New Drug Application (ANDA) litigation that involved payments and/or provisions to delay bringing an authorized generic product to market for a defined time period||HC-BP-240b.1||Not Applicable to animal pharmaceuticals|
|Percentage change in: (1) average list price and (2) average net price across U.S. product portfolio compared to previous year||HC-BP-240b.2|
We do not publicly disclose changes in average list price, as that information is competitively sensitive.
On a global basis, the effect of price on changes in revenue as compared to the prior year was as follows:
2022 – 2%
2021 – 2%
2020 - 3% *
2019 – 2% *
2018 – 3% *
*Data for 2018-2020 reflects legacy Elanco operations, prior to the integration of Bayer Animal Health.
|Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous year||HC-BP-240b.3||While we are not reporting a percentage change in net list price, no single product materially contributed to our price growth in 2022.|
|Drug Safety||List of products listed in the Food and Drug Administration’s (FDA) MedWatch Safety Alerts for Human Medical Products database||HC-BP-250a.1||Animal health products are not included in the FDA MedWatch Safety Alerts publication.|
|Number of fatalities associated with products as reported in the FDA Adverse Event Reporting System||HC-BP-250a.2||We continually assess, record and analyze any potential safety and quality defects associated with the use of any of our products. Our pharmacovigilance and quality assurance process requires root cause analysis and evaluation, ensuring appropriate mitigating and preventative actions are implemented. Animal health products are not included in the FDA FAERs system. The FDA Center for Veterinary Medicine makes adverse events reports from the animal health industry available to the public at https://open.fda.gov/|
|Number of recalls issued; total units recalled||HC-BP-250a.3||We continuously assess, analyze and record any potential quality defects associated with our products. Should we ever determine a product quality or safety concern, we would promptly and voluntarily recall the product from the supply chain and cooperate with local regulatory authorities. In 2022, we issued 7 product recalls globally. Our quality assurance process mandates root cause analysis and evaluation for all incidences – ensuring appropriate mitigating, corrective and preventative actions are implemented accordingly.|
|Total amount of product accepted for takeback, reuse, or disposal||HC-BP-250a.4|
The total amount of product accepted for takeback, reuse or disposal is competitively sensitive. However, our operational processes for product returns are described below:
Customers in the U.S.
In the U.S., our commercial policies allow for the return of products if certain criteria are met, as outlined in the Elanco Terms and Conditions of Sale and in our commercial contracts. We investigate reasons for returns and distinguish three types of returns: Unusable, Return to Stock, or Destroyed in Field. When a product is returned at designated facilities, SOPs describe how Elanco products returned to an Elanco warehouse or third-party partners such as logistics service providers should be handled. The SOPs also outline the rules for further disposition of returned products. Our Health, Safety and Environment (HSE) organization maintains additional SOPs detailing appropriate processes for the management and disposal of both waste and hazardous waste material.
In rare instances, we evaluate a product for reintegration into the supply chain. In such circumstances, our U.S. Affiliate Quality (USAQ) team applies a standard process for assessing the product’s suitability. This is necessary to ensure that only product fit for use is considered for re-integration into saleable stock. For products destroyed in the field, we advise our customers to comply with guidelines for appropriate disposal, per the product information documents. When product is returned at a designated facility, approved procedures define how Elanco product returns are handled.
Customers Outside the U.S.
For markets outside of the U.S., our regional affiliates have local commercial policies which are based on our Commercial Policy Blueprint for Elanco International. This blueprint identifies applicable global SOPs and return procedures. The return processes defined in affiliates’ commercial policies include a local business review, approval process and requirements for the creation and retention of appropriate supporting documentation aligned with applicable local regulations and global procedures.
|Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practices (cGMP), by type||HC-BP-250a.5||In 2022, Elanco had no such FDA actions.|
|Ethical Marketing||Total amount of monetary losses as a result of legal proceedings associated with false marketing claims||HC-BP-270a.1||If applicable, we disclose information about material legal proceedings in our Annual Report on Form 10-K.|
|Description of code of ethics governing promotion of off-label use of products||HC-BP-270a.2||Elanco’s Global Marketing Operations Procedure: Promotional Materials Review and Approval ensures the development, review, approval and lifecycle management of promotional, educational and technical materials are consistent with the Elanco brand, industry standards and existing local laws. All materials provided by Elanco to animal health or nutritional health professionals and consumers worldwide are reviewed to be accurate and balanced, based on science and/or technical information, consistent with the approved label and aligned with established ethical, regulatory, legal and professional/scientific requirements. Elanco sales, marketing, technical and regulatory teams are trained on and must comply with, local and global policies with respect to labeling and promotional activities. Compliance with local and global standards is subject to periodic internal audits and policy violations may result in disciplinary action.|
|Employee Recruitment, Development & Retention||Discussion of talent recruitment and retention efforts for scientists and research and development personnel||HC-BP-330a.1||Elanco’s strategic talent recruiting group to actively support our company’s unique talent needs – including sourcing for specialized skills in R&D, IT, finance and legal. Distinct from the rest of the organization, our career path and structure in R&D is focused on ensuring appropriate opportunities based on both internal and external scientific contributions. Our diverse mentoring program supports the development of individuals within our organization, connecting people from diverse backgrounds, experiences and/or geographic locations. Creating opportunities for information sharing, cross-functional job training and on-site rotations allows our employees to understand the role that specific scientific areas contribute across all functions. We have Scientific Communities of Practice (COPs) that foster knowledge sharing and enhance the visibility of scientific talent across the organization. Succession management plans are reviewed annually for key roles to ensure continuity and to identify talent gaps supporting the advancement of our development and training initiatives.|
(1) Voluntary and (2) involuntary turnover rate for: (a) executives/senior managers, (b) midlevel managers, (c) professionals, and (d) all others
2022 Voluntary 15.8%
2022 Involuntary 14.0%
2022 Voluntary 8.1%
2022 Involuntary 6.2%
2022 Voluntary 9.0%
2022 Involuntary 10.4%
2022 Voluntary 11.7%
2022 Involuntary 7.5%
|Counterfeit Drugs||Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting||HC-BP-260a.1|
Elanco proactively identifies, attacks and frustrates the sellers and manufacturers of counterfeit products to protect our customers. Engaging with external business partners, Elanco can proactively monitor counterfeit activity for five key products in the U.S. Counterfeits are identified through a combination of internal and external resources. Evaluated through an internal assessment process conducted by technical experts. Analytical testing may be performed if further information is needed.
Notification regarding counterfeits to legal or regulatory authorities depends on local requirements and specific circumstances. To support law enforcement, Elanco has held global education training programs with more than 1,300 in attendance since 2021. The field guide is under continuous review for relevant updates.
Elanco reinforces the importance of acquiring products through authorized distributors as a mechanism to ensure product safety and quality. In the U.S., consumers may use our “Where to Buy” tool to purchase authentic Elanco products from approved veterinary clinics, e-commerce sites and pet retailers. Purchases from sites other than those listed in the Where to Buy tool may originate from a source unknown to Elanco.
|Discussion of process for alerting customers and business partners of potential or known risks associated with counterfeit products||HC-BP-260a.2||While each case is unique, there may arise circumstances which warrant communication to customers, distributors and/or consumers, where Elanco reinforces the importance of acquiring products through authorized distributors of our products as a mechanism to ensure product safety and quality.|
|Number of actions that led to raids, seizure, arrests, and/or filing of criminal charges related to counterfeit products||HC-BP-260a.3||Notification regarding counterfeits to legal or regulatory authorities depends on local requirements and specific circumstances. Our procedures ensure notification to local authorities occurs when required. If notification is not required, but authorities are receptive to reports of counterfeits, we evaluate the circumstance to determine if reporting will occur. In circumstances where regulators or law enforcement officials receive information related to counterfeit products, Elanco may or may not be informed of raids, seizures, arrests, and/or filing of criminal charges. Since its inception in 2021, Elanco's proactive counterfeit program has resulted in law enforcement actions recovering more than $2.1M worth of counterfeit product.|
Manufacturing & Supply Chain Quality Management
|Percentage of (1) entity’s facilities and (2) Tier 1 suppliers’ facilities participating in the RX-360 International Pharmaceutical Supply Chain Consortium audit program or equivalent third-party audit programs for the integrity of supply chain and ingredients||HC-BP-430a.1|
Elanco is a member of the Pharmaceutical Supply Chain Initiative (PSCI) organization. We maintain a targeted risk-based external supplier auditing program. This includes the potential completion of periodic surveys and the potential for on-site assessments to verify adherence to the PSCI principles. In 2022, we more than doubled the number of suppliers that participated in the on-site HSE PSCI assessments.
In 2023, we are establishing a formal human rights program, including a global human rights policy, an executive oversight committee and a core program team including representatives from ESG and sustainability, legal and compliance, HSE, procurement, supply chain and other departments.
This new policy reaffirms our commitment to leading human rights practices as specified in the OECD Guidelines for Multinational Enterprises, the U.N. Guiding Principles on Business and Human Rights (including the International Labour Organization Declaration of Fundamental Principles and Rights at Work) and the Pharmaceutical Supply Chain Initiative Principles for Responsible Supply Chain Management.
The policy outlines our commitments and procedures, including due diligence specifications that apply to our own operations, supply chain and other business partners. The policy also provides a global framework for regional human rights activities, including the management of modern slavery risks.
In 2023, we also expect to implement an enhanced Supplier Code of Conduct and third-party due diligence platform to ensure we receive comprehensive information from current and prospective suppliers and business partners on their practices related to more than 20 leading ESG topics. We will use this information to monitor expected practice, identify deficiencies related to Elanco policies or business norms, and to inform targeted engagement on issues such as human rights, employee health and safety, modern slavery, information security, data privacy and operational sustainability.
|Business Ethics||Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery||HC-BP-510a.1||All material legal proceedings are disclosed in the Company’s Form 10-K.”|
|Description of code of ethics governing interactions with health care professionals||HC-BP-510a.2||Elanco has a Code of Conduct applicable to all employees that guides our decisions and relationships and establishes our behavioral expectations. Training on the Code is mandatory for all employees annually. The Code is supported by policies and procedures governing ethical interactions with external third parties, including Animal Health Professionals (AHPs), government officials, charitable organizations, and others. An AHP is a natural person who is (1) a professional in the field of animal health, including a veterinarian, registered veterinary technician, veterinary nurse, animal health nutritionist, fish health specialist, or veterinary pharmacist; and (2) who prescribes, recommends, treats and/or performs clinical services in the treatment of animals. include any customers involved in prescribing, recommending, dispensing, purchasing, supplying, or administering animal health products during their professional activities. Our policies and procedures cover ethical conduct with AHPs as it relates to gifts, meals, entertainment, hospitality, speaking engagements and sponsorship for education among other topics. Elanco requires all interactions be transparent, appropriate, and associated with a legitimate business purpose avoiding any situation that may be perceived as an inappropriate way of obtaining or maintaining business or obtaining an inappropriate advantage. We expect all interactions with AHPs to comply with applicable laws, regulations, industry codes, policies, standards, and procedures governing our business. Elanco is committed to compliance with transparency and disclosure requirements globally. Violations of our Code or policies and procedures can be reported to management, our Ethics and Compliance team or to our global ethics hotline. All concerns reported are investigated, and corrective action taken as appropriate. For additional information, see our webpage at Ethics & Compliance (elanco.com).|
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