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    Eli Lilly and Co (LLY)

    Q4 2023 Earnings Summary

    Reported on Jan 10, 2025 (Before Market Open)
    Pre-Earnings Price$706.20Last close (Feb 5, 2024)
    Post-Earnings Price$742.00Open (Feb 6, 2024)
    Price Change
    $35.80(+5.07%)
    • Expansion into new indications for GLP-1 treatments like tirzepatide (Mounjaro/Zepbound): The company is exploring downstream opportunities in conditions such as NASH and other comorbidities, which could significantly increase the patient base and drive growth. Data generated in these areas will be critical for employer opt-in and access in Medicare Part D. 
    • Development of an oral GLP-1 receptor agonist (orforglipron): With over 110 million people with obesity in the U.S. and 650 million globally, and considering that approximately 20% of patients are concerned about injectables, an oral therapy like orforglipron could reach a larger patient population, offering efficacy comparable to the best competitive incretin therapies without food or water restrictions. 
    • International expansion of Mounjaro: The company is actively launching Mounjaro in several markets outside the U.S., including Australia, Canada, Germany, and Poland, and anticipates further launches throughout the year and into 2025. This international growth strategy supports further revenue growth and market share gains in the GLP-1 space. 
    1. Investment in Orforglipron Manufacturing
      Q: How are you balancing investment in capacity with orforglipron's probabilities?
      A: We're investing fully to create new capacities , building ahead of Phase III for orforglipron at risk due to its potential.

    2. Opportunity for Oral GLP-1s
      Q: How do you view the opportunity for oral GLP-1s like orforglipron?
      A: With over 110 million obese in the U.S. , injectables can't reach all; orforglipron offers an oral option with competitive weight loss and no food restrictions , appealing to patients reluctant to use injectables.

    3. Manufacturing Capacity Strategies
      Q: Will you buy rather than build to overcome manufacturing bottlenecks?
      A: We're not capital-constrained, but existing capacity isn't available ; building new capacity takes 3-4 years, so buying doesn't solve immediate needs ; over time capacity will increase, and new technologies like orforglipron will help.

    4. Impact of Novo's Acquisition of Catalent
      Q: Does Novo's acquisition of Catalent impact your supply strategy?
      A: We have questions about the transaction and need to learn more ; our focus is on ensuring uninterrupted supply and holding Catalent accountable to contracts.

    5. Future Plans for Tirzepatide in NASH
      Q: Why hasn't Lilly initiated a Phase III trial of tirzepatide in NASH?
      A: We just received positive Phase II data and are determining next steps ; nothing in the data prevents us from proceeding, but we may have better molecules like retatrutide.

    6. SYNERGY-NASH Trial Prospects
      Q: Is there a prospect for accelerated approval from SYNERGY-NASH?
      A: We're excited about the promising data from a small trial (190 participants) showing clinically meaningful improvement in fibrosis , and we look forward to discussing next steps with the FDA.

    7. SURPASS-CVOT Trial Timing
      Q: Does the delay in SURPASS-CVOT imply interim results, and is superiority needed?
      A: We don't comment on interims; the delay is due to slower event rates, which is good for patients. Superiority would be beneficial, but we remain focused on the trial's completion.

    8. GIP Agonism vs. Antagonism
      Q: How do you view GIP agonism versus antagonism?
      A: We're extremely confident in the benefits of GIP agonism based on extensive data ; antagonism may have negative effects like increased free fatty acids , while agonism may improve tolerability.

    9. Zepbound Payer Coverage Expansion
      Q: Will most payers who cover Wegovy add Zepbound this year?
      A: We have 35% commercial access early in launch , aiming to expand to levels similar to competitors, around 50%.

    10. International GLP-1 Launch Expansion
      Q: What are the hurdles to closing the ex-U.S. gap in your GLP-1 franchise?
      A: We've launched Mounjaro in markets like Australia, Canada, Germany, and Poland , received QuickPen approval in the U.K. , and will continue launching as we get approvals and increase supply capacity throughout this year and into 2025.

    11. Lean Muscle Loss and Tirzepatide
      Q: What's Lilly's take on lean muscle loss with tirzepatide vs. semaglutide?
      A: Tirzepatide improves lean-to-fat mass ratio, losing more fat than lean mass ; the ratios you mentioned seem correct, possibly due to GIP agonism benefits.

    12. Duration of GLP-1 Therapy Use
      Q: Any updates on duration of GLP-1 use in diabetes and obesity patients?
      A: It's still early, but Mounjaro shows encouraging persistency similar to other injectable incretins ; too early to gauge for Zepbound.

    13. Extended Dosing and Sustainability
      Q: What's your view on extended dosing like monthly administration and sustained efficacy off-therapy?
      A: The data on extended dosing and sustained efficacy are underwhelming ; weight loss is lower than needed for Phase III ; convenience matters but isn't the most important factor for providers and patients.

    14. Downstream Opportunities for GLP-1 Therapies
      Q: How are you sizing downstream opportunities for tirzepatide in NASH and other indications?
      A: Key drivers are increased employer opt-in and access in Medicare Part D, supported by data in comorbidities like cardiovascular and NASH.

    15. Orforglipron Safety and DDI Profile
      Q: What do you mean by orforglipron having lots to prove, and will it work with SGLT2s?
      A: As we're starting Phase III, we need to confirm safety ; we expect coadministration with SGLT2s to be possible and have it ongoing in trials.

    16. Tirzepatide in Sleep Apnea
      Q: How much benefit is needed in sleep apnea for clinical meaningfulness?
      A: There's no established threshold, but we're optimistic about tirzepatide's potential and will assess various measures to determine clinical meaningfulness.

    17. Purpose of Lilly Direct Platform
      Q: Is Lilly Direct just to streamline access, or is there a monetization model?
      A: Lilly Direct aims to streamline access for patients and serve them better , not intended as a new retail distribution business.

    18. Tirzepatide Branding Outside the U.S.
      Q: Why not launch Zepbound outside the U.S. but expand Mounjaro's label?
      A: Branding decisions depend on regulatory, competitive, and payer dynamics ; we're optimistic about commercialization under different brand scenarios.