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I'm Dave. On The Pen is my thing. My passion. But so are my 4 kids, and so is my day job. In order to sustain my efforts, I have to cover the costs involved with OTP. The website, the programs that make it pretty, and the tools that help people connect to it. A gift of ANY amount is greatly appreciated!

On The Pen: Q2 2024 Novo Nordisk Earnings Call Recap




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

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