Eli Lilly and Company (LLY) Status Update summary

Strategic transformation and portfolio modernization

• Oncology R&D has shifted since 2019, focusing on high-conviction biology, external innovation, and business development, with multiple acquisitions and collaborations to expand and diversify the pipeline.

• Nearly the entire legacy pipeline was terminated in 2019-2020, replaced by new projects and modalities, including small molecules, antibody-drug conjugates, T-cell redirectors, and radioligand therapies.

• Eight new clinical trial starts for new molecular entities are planned for 2024, reflecting the maturation of the revamped discovery engine.

• Several late preclinical and clinical assets have been initiated post-2019, spanning multiple cancer types.

• Eight pivotal randomized trial readouts are scheduled, with several first human dose studies achieved in 2024.

Commercial performance and key brands

• Oncology revenue grew from $2.99B in 2020 to $6.44B in 2023, driven by Verzenio, Retevmo, and Jaypirca.

• Verzenio leads the CDK4/6 market, with 56% global and 52% U.S. growth in 2023, and about 60% of eligible high-risk early breast cancer patients receiving the regimen.

• Jaypirca, the only FDA-approved non-covalent BTK inhibitor, saw rapid uptake after approvals in MCL and CLL, with ongoing pivotal studies and positive feedback on efficacy and tolerability.

• Retevmo has achieved tumor-agnostic approval and demonstrated strong efficacy in first-line RET-positive lung and thyroid cancers.

Clinical development highlights

• Verzenio showed a 32% reduction in invasive disease-free survival events at 5 years in high-risk early breast cancer, maintaining benefit beyond treatment.

• EMBER-3 and EMBER-4 studies are advancing imlunestrant, a brain-penetrant oral SERD, in both advanced and adjuvant breast cancer, aiming for dual approval and broad impact, with pivotal phase III data expected in 2H 2024.

• Olomorasib, a 2nd-gen KRAS G12C inhibitor, demonstrated efficacy and safety in pretreated NSCLC, with promising CNS activity and combination potential with pembrolizumab.

• Jaypirca is being studied in multiple phase 3 trials across CLL and mantle cell lymphoma, including fixed-duration and combination regimens.

• New antibody-drug conjugates targeting folate receptor and Nectin-4 are entering the clinic, aiming to address resistance and toxicity seen with earlier agents.