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pww.comEli Lilly and Company Presents at TD Cowen 44th Annual Health Care Conference 2024, Mar-06-2024 09:10 AM - NYSE:LLY

NYSE:LLY

Anat Ashkenazi [Former Executive VP & CFO] đź’¬

Anat Ashkenazi, the Former Executive Vice President and Chief Financial Officer of Eli Lilly and Company, discussed several topics during the TD Cowen 44th Annual Health Care Conference 2024. Below is a detailed summary of her comments:

General Overview

  • Robust Growth: She highlighted the company’s robust top-line growth, driven by key growth products, and projected a 20% growth rate for the year.
  • Product Launches: Mentioned the launch of the KwikPen, Mounjaro KwikPen in the UK and the release of NASH data for tirzepatide.
  • Setbacks: Noted the termination of the CYCLONE 2 and CYCLONE 3 trials for Verzenio in prostate cancer.
  • Pipeline Progress: Discussed the initiation of Phase III trials for the Lp(a) program and retatrutide in type 2 diabetes.

Lebrikizumab Approval

  • Approval Confidence: Expressed confidence in the approval and launch of lebrikizumab before the end of the year, despite a Complete Response Letter (CRL) related to manufacturing at a third-party site.
  • Patient Benefits: Highlighted the unique properties of lebrikizumab, including its efficacy and dosing frequency, positioning it as a compelling option for physicians and patients.

Manufacturing Capacity for Tirzepatide

  • Expansion Agenda: Described the company’s broad manufacturing expansion agenda, the largest in its 148-year history, including sites in North Carolina and Germany.
  • Supply/Demand Situation: Noted that production will not meet demand in 2024, with a tight supply/demand situation potentially extending into 2025.
  • Relief Measures: Mentioned the launch of the single-use vial and the KwikPen as measures to help manage the supply situation.
  • Oral Formulation: Referenced the potential of orforglipron as an oral formulation that could further expand the product offering.

Demand and Supply

  • Robust Demand: Noted the robust demand for tirzepatide in every market, including the single-use vial outside the US.
  • KwikPen Launch: Mentioned the launch of the KwikPen in the UK and plans for approval in other markets.

Donanemab PDUFA Date

  • Normal Process: Addressed the normalcy of the review process for donanemab, emphasizing that the submission is on track and there are no unusual issues.

Market Strategy for Obesity and Diabetes

  • Portfolio Depth: Described the company’s portfolio depth, covering various patient needs, including different weight loss goals and preferences for oral or injectable medications.
  • Holistic Approach: Highlighted the holistic approach to managing obesity beyond weight loss, including addressing comorbidities like NASH, obstructive sleep apnea, and heart failure.

Future Outlook

  • Broad Portfolio: Emphasized the company’s diversified portfolio across multiple therapeutic areas, including depth in each category.
  • External Assets: Noted the strategic approach to business development, focusing on early-stage assets that can leverage the company’s R&D expertise.

Conclusion

  • Exciting Future: Concluded by expressing excitement about the future of the company and its diverse range of products in development.

Andrew Adams [Vice President of New Therapeutic Modalities & Scientific Leader] đź’¬

** Key Points Mentioned by Andrew Adams**

  • Chronic Pain:

    • Fits the phenotype of big challenges Lilly addresses.
    • Massive unmet medical need and challenging regulatory environments.
    • Similar to Alzheimer's disease, where it took a long effort to change the disease trajectory.
    • Promising developments in Phase II that could disrupt the current unsatisfactory care landscape for patients with pain.

  • Obesity:

    • When joining Lilly 14 years ago, peers advised against working on obesity due to regulatory challenges and lack of scientific readiness.
    • Lilly had the foresight to see a huge opportunity to help patients.
    • Chronic pain is viewed similarly, with significant unmet needs and promising scientific advancements.

  • siRNA (Lp(a) Program):

    • Resulted in the first Phase III trial for Lp(a) at Lilly.
    • Proud of the timeline from inception to Phase III, demonstrating rapid progress.
    • Platform deals continue, with a focus on gene therapy, including the Akouos acquisition.

  • Gene Therapy:

    • Highlighted the Akouos acquisition and the successful restoration of normal hearing in a profoundly deaf child.
    • Demonstrates the power of regenerative medicine with gene therapies.
    • Expect to see expansion in this area over the next few years.

  • Donanemab (Alzheimer's Disease):

    • File is large and normal, with no out-of-the-ordinary issues.
    • Review process is out of Lilly's control, but they are following the timeline set by the agency.
    • Learning from Biogen's rollout, though not being first can provide advantages.
    • Focused on raising awareness of diagnostic tests and best practices, and ensuring a smooth rollout.

  • Lp(a) Target:

    • Strong genetic evidence and positive apheresis data.
    • High confidence in the target without Phase III data.
    • siRNAs offer convenience with a potential 6-month dosing interval.
    • Excited about the long-term potential of gene editing for Lp(a).

  • Cardiovascular Disease:

    • siRNAs are preferred for convenience, especially for daily statin users.

    • Lp(a) is a critical target as diet and exercise do not impact Lp(a) levels.

    • A medicine is essential for patients with high Lp(a) levels due to the lack of other options.

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