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Under various pressures, Novo Nordisk is cautious on 2018 guidance
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  • Publication:2017/11/1

Novo Nordisk is navigating a tough stretch thanks to increased competition and new state laws adding to the already-tough pricing pressure on the U.S. insulin market. But the drugmaker has a plan to come out ahead, looking to grow market share in diabetes,  launch Fiasp in the U.S., and get a potential nod for blockbuster candidate semaglutide.

In earnings results released Wednesday, Novo Nordisk reported that sales for the third quarter were up 2% to $4.5 billion while profit was up 5%. Last year's important diabetes launch Tresiba, stalwart Victoza and weight-loss injection Saxenda have helped fuel revenue gains for the drugmaker in the first 9 months of the year, with their sales increasing 117%, 15% and 80% versus the same period last year, respectively.  

Tresiba sales have reached $800 million so far as that med approaches blockbuster status. Victozawhich recently won an FDA cardiovascular indication that Novo hopes can fuel future gainsreeled in $2.5 billion in the first 9 months of 2017.

But overall, the drugmaker's third-quarter revenue missed analyst consensus expectations by 3% due to lower-than-expected sales for Tresiba and diabetes med Levemir, according to a note from Jefferies analyst Jeffrey Holford.

Earnings per share beat Street estimates by 3% due to lower costs and an assist from other incomes.  

With the results, the drugmaker slightly adjusted its 2017 financial expectations upward within previous ranges and presented 2018 guidance of low to mid-single-digit sales growth at local currencies. The company is guiding for low- to mid-single-digit operating profit growth next year as well but expects a 3% to 4% hit on currency effects.

Holford noted that the guidance seems below "consensus expectations, as the company faces competition … and price pressure in diabetes."

The company separately faces state-level pricing and transparency regulations in the U.S., an emerging trend that CEO Lars Fruergaard Jorgensen said could make it "difficult to do business," according to Reuters. So far, Maryland, Nevada and California have passed individual measures, with Nevada's taking specific aim at the diabetes business.

Looking ahead, the company is awaiting an FDA decision on semaglutide, a GLP-1 diabetes medication that would square off against Eli Lilly's Trulicity. After a 16-0 panel vote in favor of approval, the FDA is expected to act on the diabetes drug in the fourth quarter, according to Novo. Execs hope the med can expand the entire class, and market intelligence firm Evaluate has predicted semaglutide could reach $2.2 billion in sales by 2022.

Also this quarter is the U.S. launch for new ultrafast-acting insulin Fiasp, according to the drugmaker. Novo won approval for that drug in September, and Bernstein analysts have predicted it could reach $500 million in sales by 2020.