CEO Dave Ricks Shares Lilly's Principles of COVID-19 Antibody Therapy Pricing and Access

In February of this year, as the novel coronavirus began its deadly march across the world, we urgently mobilized our scientific and medical expertise at Lilly to fight this terrible disease. We have done in just a few months what usually takes years – while remaining committed to our rigorous standards for patient safety and product quality. And we have self-funded the research, development and manufacturing costs for our potential COVID-19 treatments, not accepting money from governments. We believe this is our role as a biopharmaceutical company – to invest in research and create new medicines for acute crises like this pandemic, as well as for other life-threatening or chronic diseases.

Our neutralizing antibody monotherapy is currently under review by global regulatory bodies, including the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 illness in high-risk patients. Bamlanivimab – as monotherapy and in combination with a second Lilly neutralizing antibody – has the potential to reduce the risk of newly diagnosed patients going to the hospital. See Lilly press releases regarding the safety and efficacy data of these potential treatments, here and here. We are hopeful our antibody therapies become part of the solution to a pandemic that has taken more than a million lives.

But our responsibility doesn’t stop with the creation of new medicines, proof of their safety and effectiveness, and quality manufacturing. We also must work with global health systems to ensure equitable access to our medicine at a fair price; our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live. This task is challenging under normal circumstances, and even more difficult given the massive scale of this pandemic, its rapidly shifting presence around the world and the complexities and capacity limitations of producing neutralizing antibodies. Our team has worked hard to amass significant manufacturing capacity – including five antibody production plants on three continents – and done so prior to a dose being defined or proof of efficacy being established. However, given lead times for production and the lack of large scale and available global manufacturing capacity for this kind of medicine, we now know there will be significantly more demand than supply for Lilly’s – and all other – antibodies currently in development.

As long as supply of neutralizing antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organizations. These institutions are best positioned to direct our antibody treatments to the patients who need them most.

What can’t happen, though, is that only the wealthiest countries or people gain access to COVID-19 treatments. Medicine must be available to patients with the greatest unmet need, not sold to the highest bidder. That’s why we have sought input from economists and ethicists and developed a set of Access and Affordability Principles for our neutralizing antibodies. Rooted in the values that have guided our company since 1876, these principles are as follows:

1. Allocation: Treatment will be allocated based on unmet medical needs globally

Based on our initial studies and global observations of this new disease, it is clear that patients with certain risk factors, including age and obesity, fare worse upon diagnosis. While many individuals may want this potential new medicine to reduce the possibility of a more serious infection, Lilly anticipates only high-risk patients will be indicated to receive the drug until more studies of our medicine are completed and more supply is available.

To guide decisions on where to send the medicine, we’re taking a data-driven approach. Priority countries and quantities of medicine will be determined using data from trusted research centers such as the John Hopkins University Coronavirus Resource Center and international health authorities such as the World Health Organization. Because the pandemic is moving fast, we’ll commit only to a few months of supply at a time to any given country so that we may best match demand and limited supply. It will be important that governments support this approach – scarce medicines that are stockpiled do not reach patients in need, and we want to ensure our antibody treatments will be available to those who need it and will use it, everywhere.

Unfortunately, the U.S. now leads the world in both COVID-19 cases and deaths. As a result, a top priority is helping reduce disease burden in the U.S., and today Lilly has entered into an agreement with the U.S. government to supply bamlanivimab monotherapy. The U.S. government will accept the vials of bamlanivimab if it is granted an EUA. The federal government, in partnership with state health departments, is developing an allocation program for the therapy.

2. Patient Cost: Our goal is for patients to have no out-of-pocket costs for our antibody treatments, wherever possible

Cost must not be a barrier to access. Our goal is zero out-of-pocket expenses, wherever possible, for any patient receiving a Lilly COVID-19 antibody treatment. For instance, the U.S. government has committed that patients will have no out-of-pocket costs for Lilly’s antibody therapy, although health care facilities may charge a fee for the product’s administration.

3. Pricing to Health Systems: Equitable government pricing will be tiered based on a country’s ability to pay

We have given significant thought to the question of what to charge for our antibody therapies during this crisis. We seek to balance a number of factors, including the value that these potential therapies could bring to society and the health care system as a whole. Neutralizing antibodies have the potential to create significant societal value if they reduce adverse outcomes and costs associated with COVID-19, including hospitalizations, which average nearly $22,000 per person in the U.S.¹

We will pursue tiered pricing arrangements for government purchases of our antibody therapies, based on the World Bank’s gross national income (GNI) per capita data. The pricing will be tiered based on countries’ ability to pay, with wealthy countries paying the same as one another, middle-income countries receiving a steep discount, and the poorest countries paying only marginal costs. We will continue our work with philanthropic organizations such as the Bill & Melinda Gates Foundation to make our antibody therapies available to these low- and middle-income countries, furthering our goal of reaching as many patients with unmet needs as we can, no matter where they live.

While the specific pricing for our potential combination therapy is not yet available, Lilly will offer bamlanivimab monotherapy at $1,250 per vial to wealthy countries, if authorized by the country’s regulators. Importantly, one vial represents the full course of bamlanivimab treatment, per our submissions to global regulators. In this price range and given volume constraints, we expect all major economies to accommodate the procurement of their share of supply within existing medicines' budgets. In choosing this price for our monotherapy, we also want to ensure that innovators of the next generation of antibodies, for this virus or the next one, have an incentive to apply their scientific teams and use their investors' resources to create new effective therapies as well. While pricing above our marginal cost to produce the medicine in developed markets, we expect to produce a modest financial return for our investors by the end of 2021.

Collaboration Is Critical to Fair and Efficient Access

Today more than ever, the world depends on strong collaborations between industry and government to get medicines to people as quickly as possible. Yet each country has nuanced regulatory requirements that could potentially cause delays: health authority reviews, licensing agreements, customs duties, document translations, supply chain preparations and administrative protocols. It’s critical that governments act now to streamline the complex processes that will be required for swift approval and distribution of COVID-19 treatments.

It’s equally important that we don’t let national interests cost us precious time in the fight against COVID-19. We’re in the midst of a global pandemic and political leaders around the world must support the collaboration needed to deliver solutions to patients in need, even if those patients live outside their own country. This virus doesn’t know or care about our national borders, so persistent disease in any one country is a risk to citizens in all countries.

There are over 550 initiatives underway worldwide to develop and test treatments and vaccines against COVID-19. The speedy progress of these initiatives has been enabled through the support and partnership of governments – by streamlining regulatory procedures, sharing data and expertise, and removing barriers to collaboration among industry, academia and public agencies.

We can build on this collaboration to swiftly deliver future COVID-19 solutions to patients with the greatest unmet needs.

Every day, our industry must balance increasing access to proven treatments with researching and discovering new ones. The pandemic poses a historic opportunity to do both. COVID-19 is an urgent and pressing threat. But I’m confident that, through science, we will beat it and emerge stronger as a global community to fight the next pandemic.

¹ Premier Applied Sciences®. Premier Healthcare Database white paper: data that informs and performs March 2, 2020. www.premierinc.com/pas.

Lilly Cautionary Statement Regarding Forward-Looking Statements

This document contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, as well as its supply, cost and potential regulatory approval. This document reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that studies will complete as planned, that future study results will be consistent with the results to date, that bamlanivimab will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab will receive regulatory approvals or authorizations, or that we can provide an adequate supply of bamlanivimab in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.