Eli Lilly & Co

Performance in the 2024 Index

19th place. Eli Lilly is in the lower ranks of all Technical Areas. It is newly engaged in technology transfer and improved in Governance of Access; however, it provides limited evidence of access strategies for products analysed in Product Delivery. 

Opportunities for Eli Lilly

Improve the quality and broaden the geographic reach of access plans. Eli Lilly has access plans in place for most of its late-stage R&D projects. However, these plans solely focus on committing to registering in countries where clinical trials are conducted (predominantly upper-middle income countries). It can enhance these plans by considering more access provisions, such as affordability, and expand them to include more low and lower-middle-income countries within scope. For example, Eli Lilly can expand its access plan for its GLP-1 inhibitor orforglipron, which is currently in Phase III clinical trials for type 2 diabetes, beyond commitments to make it available in the three countries in scope where it is conducting trials.

Implement robust access-to-medicine incentives for senior management. Eli Lilly has an access-to-medicine strategy, and the company shows that access incentives for the CEO are in place. It could provide evidence of similar access incentives for its senior executives and in-country managers in low- and middle-income countries (LMICs). 

Engage in technology transfer initiatives with manufacturers in LMICs to improve availability and affordability.  In 2022, Eli Lilly entered a partnership with a local manufacturer in Egypt and in 2023 with a local manufacturer in Bangladesh to manufacture and supply human and analogue insulins to African countries and Bangladesh, respectively. The company can engage in similar initiatives to build manufacturing capacity and improve regional availability of insulins in countries or regions with specific access gaps. 

Expand access strategies to innovative cancer products. Eli Lilly has an agreement to supply abemaciclib (Verzenio®), indicated for breast cancer, through product donations in Kenya (LMIC), but did not report any additional access strategies for its oncology products in other countries in scope. It can expand access to its products, particularly to abemaciclib, which has been prioritised for voluntary licensing by public health organisations, through equitable pricing strategies and/or engaging in voluntary licensing to enable generic supply. 

Changes since the 2022 Index

• Engaged in a new technology transfer with EVA Pharma, an Egyptian manufacturer for human and analogue insulin, since 2022. Through this collaboration, Eli Lilly supplies an API to produce insulin at a reduced price and provides a pro-bono technology transfer. 

• In September 2024, after the period of analysis, Eli Lilly announced a voluntary licensing agreement and technology transfer with EVA Pharma to manufacture and supply baricitinib (indicated for rheumatoid arthritis, COVID-19 and other inflammatory conditions) in 49 LMICs in Africa. 

• Donated USD 14.4mn in 2022  to address non-communicable disease (NCD) risk factors, strengthen health systems and enhance the ability of healthcare workers to care for patients in Bangladesh, Malawi, Nepal, the Philippines and Zimbabwe through the United States Fund for UNICEF; subsequently, in 2024 it expanded this commitment by donating USD 6.5mn to patients in resource limited settings in India. 

• Collaborated with International Agencies (Bangladesh) Ltd. to supply its API for human insulin at a reduced price to a third-party manufacturer in Bangladesh. 

• Shows publicly available evidence of conducting fraud-specific risk assessments to mitigate risk of non-compliant and corrupt activities. 

• Joined the Coalition for Access to Oncology Medicines and Products in 2023, which aims to increase availability of affordable essential medicines and products for NCDs, starting with diabetes, hypertension and cardiovascular diseases. 

• Announced a new partnership with Direct Relief in January 2023 to build cold chain capacity of Life for a Child facilities in 17 countries in Africa, Latin America, the Caribbean and Southeast Asia. 

• In 2023, Eli Lilly divested its worldwide commercial rights for its entire olanzapine (Zyprexa®) portfolio to Cheplapharm for USD 1.35bn and divested glucagon (Baqsimi®) to Amphastar Pharmaceuticals for USD 1.08bn. 

• Announced a collaboration with OpenAI in June 2024, after the period of analysis, through which it will leverage OpenAI's generative artificial intelligence (AI) to invent novel antimicrobials to treat drug-resistant pathogens. 

Sales and Operations

Therapeutic areas: Bone muscle joint, cancer, cardiovascular, COVID-19, diabetes, endocrine, immunology, neuroscience, obesity 

Product categories: Innovative medicines 

M&A news: In 2022 Eli Lilly acquired Akouos for USD 610mn. In 2023, it acquired Mablink Biosciences and Immunitrack for undisclosed amounts; Point Biopharma Global for USD 1.4bn; Dice Therapeutics for USD 2.4bn; Versanis Bio for USD 1.93bn; Emergence Therapeutics for USD 470mn, and Sigilon Therapeutics for USD 309.6mn. 

Sample of pipeline and portfolio assessed by the Index

PIPELINE for diseases in scope

Eli Lilly has 25 R&D projects in scope, none of which target priority diseases. All 25 projects target other diseases in scope, including cardiovascular diseases (8), diabetes mellitus (8) and cancer (5). Of the 25 R&D projects, 16 are in late-stage development, with evidence of access planning for 75% (12/16) of these. 

PORTFOLIO as selected for analysis by the Index

Eli Lilly has 26 medicines in scope, 6 of which are listed on the WHO EML. Most of the company’s medicines are on patent (18). Its medicines mostly target non-communicable diseases, such as diabetes (15) and cancer (5). Its 2 medicines for communicable diseases treat coronaviral diseases. 

Performance Breakdown

Governance of Access

RANK 17th, SCORE 3.28 

Eli Lilly performs poorly in this Technical Area. The company incentivises its CEO to act on access to medicine but does not disclose whether in-country managers and senior executives are also incentivised. It discloses information on its approach to payments to healthcare professionals. However, it does not provide evidence of a public policy that commits to ensuring ethical interactions with healthcare professionals. Further, it does not publicly express any support for the Doha Declaration on TRIPS and Public Health. 

The highest responsibility lies directly with the Board, and specifically with Executive Committee members responsible for access strategies and reporting to the CEO. Additionally, the CEO has access-related incentives linked to its ability to drive the Lilly 30x30 initiative and ensure progress. Eli Lilly does not disclose, however, whether senior executives and in-country managers are also incentivised toward access goals. 

Comprehensive access-to-medicine strategy integrated within the overall corporate strategy. Its strategy covers some of the therapeutic areas in which the company is involved. Eli Lilly publicly discloses its commitments to access to medicine, along with company-specific measurable targets, goals and objectives. Reporting is clear, linked to these goals, centrally available, and updated regularly on its website. 

Shows comparatively poor commitment to responsible business practices. There is evidence that Eli Lilly sets individual-level targets for sales agents, but the company does not disclose, publicly or otherwise, if incentives are solely based on sales volume. Additionally, it has a statement on payments to healthcare professionals but does not offer evidence of a public policy that commits to ensuring ethical interactions with healthcare professionals that aligns with the standards set by the Index. Further, it only publicly discloses information on transfers of value to healthcare professionals in countries in scope if required by law or local regulation. 

Has robust set of controls to promote ethical conduct and mitigate risk to ensure that governance efforts are not undermined by non-compliant or corrupt activities. Eli Lilly performs strongly in this respect. It has policies to mitigate non-compliance risks, including processes to ensure third-party compliance with company standards, fraud-specific risk assessments and region or country risk-based assessments. Eli Lilly lacks a framework, but its code of business conduct guides ethical employee decision-making. No breaches in countries in scope were found in the period of analysis. 

Eli Lilly does not publicly share any support for the Doha Declaration on TRIPS and Public Health. It has a publicly available policy on intellectual property, but it does not align with principles embodied in the Declaration. 

Fulfils most criteria with its process for measuring and reporting the patient reach of its Lilly 30x30 initiative. The process covers all its products and most countries in scope of the Index and Eli Lilly publicly provides the underlying equation, metrics and assumptions. The resulting patient reach numbers were published from 2020 to 2023 and demonstrate improvements. The process also has a measurable patient reach goal but no associated health outcomes goal was identified. 

Research and Development

RANK 19th, SCORE 1.35 

Eli Lilly performs poorly in this Technical Area. Eli Lilly now has an access planning framework in place for a subset of its R&D projects. The company does not engage in R&D for priority diseases but has access plans for most of its non-communicable disease projects – although plans focus on registration preparation in emerging markets. It does not publicly disclose disaggregated R&D investment data, although it newly engages in R&D capacity building initiatives. 

Structured process in place to develop access plans during R&D. The process is intended to be applied to a subset of R&D projects in scope. The company does not make a public commitment addressing its approach to access planning for LMICs. 

Eli Lilly does not have any projects in the company pipeline that target a priority disease in scope. 

Average-sized pipeline, compared to peers, addressing other diseases in scope, with 75% (12/16) of late-stage projects covered by access plans. The company has 16 late-stage R&D projects targeting diseases in scope that have not been established as a priority by global health stakeholders. The projects mainly target cardiovascular diseases, diabetes mellitus and cancer. Eli Lilly provides evidence of access plans for 12 of its 16 late-stage projects. Access plans include registration preparation and the inclusion of special populations in clinical trials. 

Eli Lilly does not publicly disclose R&D investment data disaggregated by disease category, product type or phase of development. Furthermore, it does not disclose disaggregated R&D investment data to global health organisations.* 

One R&D capacity building initiative was included for analysis, but it does not meet all Good Practice Standards (GPS). Through this initiative, Eli Lilly aims to build R&D capacity in Ghana through hands-on clinical training for health workers. 

_{*Eli Lilly currently has no pipeline candidates within the disease scope of Impact Global Health (formerly known as Policy Cures Research), an organisation that assesses disaggregated R&D data.} 

Product Delivery

RANK 20th, SCORE 1.72 

Eli Lilly performs poorly in this Technical Area. It is newly engaged in technology transfers for its products as well as supply chain capacity building; however, its access strategies for products analysed are limited. The company does not engage in non-exclusive voluntary licensing or show evidence of engaging in inclusive business models. 

Eli Lilly registers products in 20 countries in scope on average. For newer products** it registers in 6 countries in scope on average and it registers 66% of products assessed in at least 1 of the 10 countries with the highest disease burden. There is evidence of registration in LICs for all products assessed. The company’s insulin glargine (Basaglar®), indicated for diabetes mellitus, is most widely registered, totalling 37 countries in scope. Eli Lilly did not report participating in any mechanisms to facilitate registration. 

_{**Products that received their first marketing authorisation within the last 5 years.} 

Eli Lilly is not eligible for assessment of supranational access strategies because it has no products in scope that are supranationally procured. 

No evidence of access strategies for its healthcare practitioner (HCP)-administered product. Eli Lilly has not reported, either publicly or to the Index, access strategies for its cancer product, ramucirumab (Cyramza®), which is assessed by the Index in this category. 

Evidence of access strategies for some self-administered products, but no data on the outcomes of these strategies. Eli Lilly has not reported to the Index access strategies for any of the 5 products assessed under this category. Of the 5 products, 4 are indicated for diabetes mellitus treatment, including 2 human insulins and 1 analogue insulin; the fifth product is a cancer treatment. The company has engaged in a collaboration to supply its active pharmaceutical ingredient (API) for human insulin at a reduced price to a third-party manufacturer in Bangladesh (LMIC). As part of the Lilly 30x30 initiative, the company has also made a similar agreement with EVA Pharma, operating in Africa, including a technology transfer for insulin vials and cartridges manufacturing. Furthermore, the company has announced an agreement with the Max Foundation to provide access to their oncology drug abemaciclib (Verzenio®) in Kenya (LMIC). However, the outcomes of these access strategies are unclear. 

Eli Lilly publicly commits not to file for or enforce patents for all products in all least developed countries in scope. 

Publicly discloses product patent status for countries in scope. Like most peers, Eli Lilly publicly discloses patent information for small molecules in scope via the Pat-INFORMED database, including information such as filing date, grant number, grant date and jurisdiction. 

Eli Lilly does not engage in non-exclusive voluntary licensing for products in scope.   

One of the 2 manufacturing capacity building initiatives included for analysis meets all GPS. For example, in 1 initiative with Egyptian manufacturer Eva Pharma, Eli Lilly is transferring technology needed to formulate, fill and finish vials and cartridges of its human and analogue insulin. Eli Lilly will work with the manufacturer to ensure that their products achieve WHO prequalification. 

None of the 3 supply chain capacity building initiatives included for analysis meet all GPS. Despite not meeting all GPS, in 1 initiative, Eli Lilly is partnering with Direct Relief to build cold chain capacity in 17 countries. Eli Lilly funding will go towards purchasing refrigeration units to support supply of quality-assured insulin products through the Life for a Child programme. 

Three of the five health system strengthening initiatives included for analysis meet all GPS. For example, Eli Lilly is supporting UNICEF through a USD 14.4mn grant to address noncommunicable disease risk factors, strengthen health systems and upskill health workers. The initiative targets Bangladesh, Malawi, Nepal, the Philippines and Zimbabwe, aiming to improve health outcomes for 10mn children through 2025. 

Eli Lilly has not entered into any new IP-sharing agreements, nor has it continued any existing agreements, with public research institutions or drug discovery initiatives to accelerate drug development. 

Fulfils most criteria for ad hoc donations. Eli Lilly has public policies and supply processes to carry out ad hoc donations rapidly in response to expressed need, with delivery monitored to ensure donations reach patients. However, it does not make commitments, publicly or otherwise, to adhere to the most recent WHO Guidelines for Medicine Donations. 

Fulfils most criteria for mechanisms to ensure continuous supply in LMICs. For example, Eli Lilly is partnering with International Agencies (Bangladesh) Ltd to supply APIs at a reduced price so that the manufacturer can formulate, fill and finish insulin vials and cartridges for local distribution. 

Eli Lilly has a policy for reporting substandard and falsified medicines in countries in scope. It reports cases to national or local regulatory authorities. However, the company does not disclose evidence, publicly or to the Index, that it requires reporting to occur within 10 days. Instead, Eli Lilly reports that it follows locally mandated reporting requirements and timeframes. The company also does not provide evidence of shortened timeframes for reporting cases that require visual inspection for confirmation.  

No evidence of inclusive business models that meet inclusion criteria.