FINANCIALS IN OBESITY AND DIABETES
Wegovy and Ozempic missed sales expectations
Lowered profit expectations (lower realized prices for GLP franchise largely driven by competition)
Slightly raised sales expectations (increase in supply, not expected to be inhibited by competition)
Novo serves 42M patients with diabetes and obesity
37% growth in obesity market in US
34% market share in diabetes
56% market share in GLP-1
10M people in US living with obesity have coverage for Wegovy via 20 states which include medicade coverage
CLINICAL TRIAL UPDATES AND KEY UPCOMING DATES
Novo has abandoned their once monthly GLP/GIP but will advance their once weekly from phase 2
Amycretin is a single formulation (phase 2 starts in second half of 24)
Oasis 4 trial completed 25mg semaglutide oral for obesity - superiority to placebo 13.6% reduction in body weight vs. 2.2% with placebo
Release is contigent on portfolio prioritization and manufacturing capacity (api)
Select trial label expansion 20% MACE reduction
STEP HFpEF trial results pulled from FDA approval in US EU, with hopes for resubmittal in 2025 with additional data available with the hope of adding hard endpoints
7.2mg STEP Up trial phase 3 results around the turn of the year
First phase 3 results for REDEFINE-1 in obesity in 2024
Phase 3 read out of Essence trial measuring 2.4mg semaglutide in MASH
Monlunabant (oral small molecule canabinoid receptor inverse agonist) weight loss expected around 15% in phase 1.
Potential to combine monlunabant with semaglutide SUPPLY
Reduced lower dose supply of Wegovy in May, increased early this year, writing double the scripts vs beginning of 2024
Demand still expected to exceed demand
Will continue to have near term issues with the .25 as they prioritize higher doses
Capping the .25 dose to control how many people start Wegovy (through 2024)
Prioritizing continuity of care, believe that separates them from competition
Supply will continue to be an issue through 2024, though they are feeling more confident in maintaining supply as time goes on
Catalent expected to close towards end of 2024, significantly expand finish/fill with 2 new sites
They are rapidly expanding infrastructure to manufacture cagrisema dual chambered pens
The are looking at formulations that could allow for cagrilintide and semaglutide to be delivered in a single mixture which would negate the need for dual chambered pens and assist in scalibility
Scaling API sites
Large focus on serving higher volumes of patients at lower price points
Patients currently use Wegovy for around 6 months, Novo believes that is supply related and expect that number to land closer to 12 months
تعليقات