Covid-19 disappoints, so Lilly sets out broader goals

Lilly confirmed today that infused monoclonal antibodies for Covid-19 are unlikely to live up to high commercial hopes, despite impressive clinical data. The company shaved half a billion dollars off its 2021 sales guidance alongside first-quarter results, on lower than expected sales of bamlanivimab and etesevimab. This opportunity was always going to be short term, of course, and more notable from the company today were updates on projects with much greater longevity. Development of tirzepatide, its next big hope in diabetes, is being scaled up to include Nash and heart failure; the gating trial for submission in diabetes, Surpass-4, will read out mid-year. Lilly’s “triple G” tri-agonist will move into mid-stage development, with executives talking up the project's potential and claiming that efficacy could exceed tirzepatide, making this a key metabolic project to watch. Meanwhile, a trial of “thousands” will be started mid-year with donanemab, testing the amyloid-beta MAb in a preventative setting; enrolment will take around a year, while events should take around three years to accrue. These will be costly endeavours, which perhaps help explain Lilly’s decision to abandon its pursuit of approval of mirikizumab in psoriasis, a very crowded field.

Project Update
Tirzepatide  Surpass-4 (T2D with increased CV risk) data due mid-year; Surmount-1, first ph3 obesity trial, topline due next year; ph3 trials getting under way in obesity (Surmount-J) and obesity with HFpEF (Summit)
Basal insulin-FC  Once-weekly project in ph2; update due at ADA conference mid-year
GGG tri-agonist To move into ph2 in type 2 diabetes, Nash and obesity; update at ADA conference mid-year
Donanemab  Alzheimer's prevention trial, Trailblazer-Alz3, to start later this year; no path for filing on Trailblazer-Alz
Verzenio FDA asked for further overall survival data as part of review in adjuvant breast cancer, based on Monarch-E
Mirikizumab Psoriasis abandoned, development to focus on Crohn's & ulcerative colitis
CD73 inhibitor Ph1 cancer asset abandoned
ANGPTL3/8 MAb Ph1 cardiovascular asset abandoned
Source: Lilly Q1 statement/conference call. 

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