- Looking at the first nine months of 2017, Novo Nordisk A/S' sales overall rose by 2% to 83.7 billion Danish kroner ($13.1 billion). The period was buffered by strong growth in its core diabetes segment —particularly its next-generation insulins. Sales of Tresiba rose by 117% to 5.4 billion Danish kroner ($800 million), with a 249% increase in sales of Xultophy and a 187% jump in Ryzodeg revenues.
- Yet, sales from its products outside its core metabolic space were down or flat for the year. That segment, which includes Novo's hemophilia products, slumped by 18% to 14.0 billion Danish kroner ($2.2 billion) The drop was the result of generic competition for the hormone replacement therapy Vagifem, and the impact of rebate adjustments for human growth hormone in the first quarter.
- Novo's best-selling product, the glucagon-like peptide-1 (GLP-1) antagonist Victoza, rose by 15% so far this year to 16.9 billion Danish kroner ($2.6 billion), despite increased competition in the space and pushback from payers.
Tresiba (insulin degludec) has been one of Novo Nordisk major growth stories so far in 2017, with a sales increase of 117% compared with the same time last year. This is at least in part driven by the drug's European label update, which reflects its significant reduction of the risk of severe hypoglycemia. Feedback on the U.S. submission for a label update is expected during the first quarter of 2018.
While all of the company's modern insulins like Levemir (insulin detemir) still bring in more money for the company, the next-gen insulin is rapidly becoming a key product for the company.
"Levemir has shown a sales decline, and its sales are gradually being cannibalized by Tresiba. There has been less of an impact on Tresiba by Eli Lilly's Basaglar [insulin glargine]," said Novo CFO Jesper Brandgaard. "Tresiba's meaningful difference in hypoglycemia is a benefit to patients and we will prioritize it in all European markets."
Tresiba is now approved in 56 countries, where it is taking an increasing share of the basal insulin segment. But it still has grount to make up in the U.S. where it only has a 9.2% share of the market, Though Novo hopes that will continue to increase due to recently-announced changes to formulary access, including Medicare Part D, CVS Health and United Health.
"The changes will provide an opportunity for patients to move from Sanofi's Lantus [insulin glargine] to Tresiba or Basaglar," added Brandgaard, addressing the Lantus copycat product that Lilly manufactures.
Another key areas for Novo is the GLP-1 space, where Victoza (liraglutide) continues to dominate. A new once-weekly offering, semaglutide, is pending approval in both the U.S. and Europe, and could add another layer of competitive advantage for the Danish drugmaker.
In August, semaglutide beat out Lilly's Trulicity (dulaglutide) in a head-to-head study comparing the two GLP-1 antagonists. Semaglutide treatment led to significantly greater weight loss, and significantly more people reaching HbA1c levels at or below 7% —the level recommended by the American Diabetes Association.
"We expect feedback from the FDA and the European Medicines Agency later this quarter," said CEO Lars Fruergaard Jørgensen. Novo Nordisk is currently preparing the global launch of semaglutide, which the company hopes will be during 2018.
In 2018, Novo Nordisk's sales and marketing priorities will lay around its largest growth drivers.
"Semaglutide could be Novo Nordisk's largest opportunity so far," said Brandgaard. "We will go all in when we have the opportunity. Tresiba still has significant opportunities in the U.S., and Saxenda is still a focus."
Novo Nordisk is remaining realistic, though, and recognizes that semaglutide's uptake is likely to be gradual following launch, particularly as it may come in 'out of season' for negotiations for market access.
"While it will depend on the label we get, we will look to establish a strong position in the mindset of endocrinologists and GPs. There will be a high degree of focus from our sales force," said Brandgaard.