Eli Lilly and Company - Special Call - NYSE:LLY

NYSE:LLY

Here is a detailed list of what Kevin Hern, the Vice President of Investor Relations at Eli Lilly and Company, said during the conference call:

1. Introduction:

   • Thanked everyone for joining the call for Eli Lilly and Company's SARS-CoV-2 Neutralizing Antibody Update.
   • Introduced himself and the other executives present on the call: Dave Ricks (Chairman and CEO), Dr. Dan Skovronsky (Chief Scientific Officer), and Josh Smiley (Chief Financial Officer).

2. Forward-Looking Statements:

   • Mentioned that the call would include projections and forward-looking statements based on current expectations, with a note that actual results could differ materially due to various factors.

3. Transition to Dave Ricks:

   • Turned the call over to Dave Ricks for introductory comments.

4. Q&A Session Instructions:

   • After the presentation, he instructed the operator to provide instructions for joining the Q&A session and indicated readiness for the first caller.

5. Moderating Q&A:

   • During the Q&A, he directed questions to the appropriate executives, primarily to Dan Skovronsky for scientific inquiries and to Josh Smiley for financial and partnership-related questions.

6. Closing Remarks:

   • Thanked participants for their interest in the company and encouraged them to follow up with the Investor Relations or communication teams for any additional questions that were not addressed during the call.
   • Wished everyone a good rest of the day and concluded the call.

This summary captures Kevin Hern's contributions and role during the conference call, focusing on his introduction, moderation of the Q&A, and closing remarks.

Here is a detailed list of comments made by David A. Ricks, Chairman, CEO & President of Eli Lilly and Company, during the conference call:

1. Introduction and Context:

   • Thanked everyone for joining the call.
   • Emphasized Lilly's commitment to mobilizing scientific and medical expertise to combat the COVID-19 pandemic.
   • Mentioned the initial predictions about monoclonal antibody therapy being a viable treatment for moderate and severe COVID-19 patients.

2. Progress and Partnerships:

   • Expressed pride in the progress made by Lilly in developing treatments for COVID-19.
   • Acknowledged contributions from partners, including AbCellera, Junshi Biosciences, NIH, and NIAID, as well as investigators and patients involved in clinical trials.

3. Updates on Treatments:

   • Highlighted the submission of an initial request to the FDA for emergency use authorization (EUA) for LY-CoV555 monotherapy for higher-risk patients with mild to moderate COVID-19.
   • Announced the potential supply of up to 1 million doses of LY-CoV555 monotherapy by the end of the year.
   • Discussed the positive results from combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies, which met primary and secondary endpoints in clinical trials.

4. COVID-19 Situation:

   • Noted the recent surge in COVID-19 cases in the U.S. and Europe, reinforcing the need for effective treatments and vaccines.

5. Future Plans:

   • Mentioned plans to submit a subsequent request to the FDA for emergency use authorization for combination therapy in November, pending additional safety data and supply.
   • Stressed the importance of continuing to develop new treatments for COVID-19 and the need for collaboration across the industry and with regulators.

6. Distribution and Access:

   • Discussed the importance of working with the U.S. government and other countries for fair allocation of the antibody treatments, especially in hotspots with significant outbreaks.
   • Emphasized the goal of ensuring that patients have no or very low out-of-pocket costs for receiving the therapy.

7. Economic Considerations:

   • Addressed the complexity of pricing and the intention to create value for society beyond Lilly.
   • Mentioned plans for a tiered pricing scheme based on GDP per capita to ensure equitable access to the treatment.

8. Closing Remarks:

   • Reiterated Lilly's commitment to fighting COVID-19 and the importance of advancing potential treatments to address unmet medical needs.
   • Thanked participants for their interest in the company and encouraged follow-up with the Investor Relations team for any additional questions.

These points summarize the key messages and themes presented by David A. Ricks during the conference call.

Here is a detailed summary of the key points made by Daniel M. Skovronsky during the Eli Lilly and Company SARS-CoV-2 Neutralizing Antibody Update Conference Call:

1. Introduction to Antibodies:

   • Discussed the two antibodies being focused on: LY-CoV555 (discovered by NIH and AbCellera) and LY-CoV016 (isolated from a patient in China by Junshi).
   • Both antibodies are high-affinity, neutralizing antibodies targeting the receptor binding domain of the SARS-CoV-2 spike protein.

2. Clinical Trials Overview:

   • Described the design of the BLAZE-1 Phase II trial, which includes three parts focusing on different patient populations.
   • Emphasized the focus on the ambulatory population (recently diagnosed patients with mild to moderate COVID-19) and the ongoing studies in hospitalized patients and post-exposure prophylaxis.

3. Trial Results:

   • Presented data showing that both monotherapy and combination therapy were generally well tolerated with no significant safety concerns.
   • Discussed the viral load outcomes, indicating that combination therapy achieved statistical significance in reducing viral load at multiple time points compared to placebo.
   • Highlighted the importance of viral load as a predictor of clinical outcomes, noting that patients with persistently high viral loads were more likely to experience severe outcomes.

4. Persistent High Viral Load (PHVL):

   • Analyzed the percentage of patients with PHVL, showing that treatment with monoclonal antibodies significantly reduced the incidence of PHVL compared to placebo.
   • Stated that patients who failed to clear the virus were at higher risk for hospitalization and worse symptoms.

5. Hospitalization and Symptoms:

   • Reported on the rates of COVID-related hospitalizations and ER visits, noting that the treatment arms had significantly lower rates compared to placebo.
   • Discussed the impact of treatment on symptom scores, showing that both monotherapy and combination therapy led to statistically significant improvements in symptoms.

6. Resistance Variants:

   • Addressed the presence of naturally occurring resistant variants in the virus, noting that these variants were found in both placebo and treatment groups.
   • Emphasized that combination therapy showed a lower prevalence of resistant variants compared to monotherapy.

7. Next Steps:

   • Confirmed that the study remains ongoing and that they are planning to initiate a large open-label pragmatic study.
   • Mentioned the intention to explore lower doses of the antibodies to stretch supply and help more patients.

8. Emergency Use Authorization (EUA):

   • Discussed the submission for EUA for LY-CoV555 monotherapy and the anticipated submission for combination therapy.
   • Expressed confidence in the safety data collected and the appropriateness of pursuing EUA based on the current data.

9. Patient Population and High-Risk Definition:

   • Clarified that high-risk patients were defined based on age and BMI, with ongoing discussions with the FDA to refine this definition.

10. Subcutaneous Administration:

    • Mentioned that they are exploring other routes of administration, including subcutaneous delivery, and that ongoing experiments will help determine feasibility.

11. Comparative Analysis with Other Antibodies:

    • Acknowledged the challenges in making direct comparisons with other companies' antibody therapies, such as Regeneron, but noted similar trends in data regarding viral load and clinical outcomes.

12. Conclusion:

    • Reinforced the commitment to continue advancing potential treatments for COVID-19 and the importance of ongoing clinical trials to gather more data.

This summary encapsulates the main points made by Daniel M. Skovronsky during the call, reflecting his insights on the development and clinical evaluation of Eli Lilly's SARS-CoV-2 neutralizing antibodies.