Novo Nordisk's Q3 profits throttle as Wegovy surges despite shortages

02 Nov 2023
firstwordpharma.com
AcquisitionDrug ApprovalPhase 3
Headline results for the third quarter:
Revenue: DKK 58.7 billion ($8.3 billion), up 29%
Profit: DKK 22.4 billion ($3.2 billion), up 56%
Note: All changes are versus the prior-year period unless otherwise stated
What the company said:
"We are very satisfied with the sales growth in the first nine months of 2023," remarked CEO Lars Fruergaard Jørgensen, noting that "more people than ever are benefiting from our innovative diabetes and obesity treatments.”"
"The acquisition of ocedurenone for the treatment of cardiovascular disease supports our aspiration of establishing a presence in other serious chronic diseases with high unmet medical needs," Jørgensen added. He expressed satisfaction with the company's decision to halt the FLOW kidney outcomes trial for Ozempic (semaglutide) early based on positive interim analysis results. The trial's final analysis findings are expected in the first half of 2024.
Other results:
Diabetes segment: DKK 42.5 billion, up 18%
Ozempic: DKK 23.9 billion, up 56% on a constant exchange rate (CER) basis
Rybelsus: DKK 4.5 billion, up 59% at CER
Victoza: DKK 2.2 billion, down 21% at CER
Tresiba: DKK 1.9 billion, down 10% at CER
Levemir: DKK 984 million, up 12% at CER
Obesity care segment: DKK 12.2 billion, up 200%
Wegovy: DKK 9.6 billion, up 734%
Saxenda: DKK 2.6 billion, down 18%
Rare disease segment: DKK 3.9 billion, down 24%, owing to a temporary reduction in manufacturing output
NovoSeven: DKK 2.0 billion, up 4% at CER
Looking ahead:
Novo Nordisk has revised its sales growth projection for the year to between 32% and 38% on a CER basis, up from earlier guidance of 27% to 33% issued in August. The company stated that enhanced sales forecasts stem from the increased full-year projections for Ozempic sales volume in the US, as well as adjustments in gross-to-net sales for both Ozempic and Wegovy in the country. Meanwhile, operating profit is now seen up by between 40% and 46%, also at constant currencies, hiked from an earlier range of 31% to 37%.
The company reiterated that owing to high demand for Wegovy, the limited supply of lower dose strengths in the US, which started in May, continues to be enforced. Indicating a gradual expansion of the company's manufacturing capabilities to counter the supply issues, Jørgensen stated "we don't see a 'hockey stick' development where suddenly there'll just be a significant ramp-up in sales."
The company still plans to contract a third manufacturer this year to help produce Wegovy, said chief financial officer Munk Knudsen, adding that "specifically on the US market, we'll be supplying significantly more in 2024 compared to what we are in 2023." Company officials also said Novo Nordisk has applied for a Wegovy label expansion in the US and Europe to include reducing the risk of cardiovascular events based on outcomes in the Phase III STEP HFpEF trial.
What analysts said:
Analysts are seeking clarification on the resolution timeline for the Wegovy shortage, especially with Eli Lilly anticipating a US label expansion later this year for Mounjaro (tirzepatide) – currently approved for diabetes – as a weight-loss treatment.
"Overall, a strong set of numbers from Novo Nordisk - driven by Wegovy," remarked Brian Godsk Borsting, analyst at Danske Bank, adding that the drugmaker is investing in production capacity for Wegovy to address short-term constraints, anticipating future relief with the drug's broader launch in various markets.
Pipeline updates:
In September, the company commenced REIMAGINE 2, the first Phase IIIa trial for CagriSema (cagrilintide-semaglutide) in individuals with type 2 diabetes, marking the initiation of the pivotal REIMAGINE programme.
Additionally, Phase I trials for subcutaneous amycretin and an ANGPTL3i monoclonal antibody were kicked off recently. In the rare diseases space, Alhemo (concizumab) gained approval in Japan for haemophilia A and B with inhibitors, and is set to launch in the first half of 2024.
($1 = DKK 7.01882)
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