Novo Nordisk quells diabetes pricing fears with 2015 growth forecast

Novo Nordisk ($NVO) has made diabetes-minded investors very happy today. Rather than following Sanofi's ($SNY) discouraging announcement of flat sales expectations in the field next year, the Danish drugmaker said it's expecting growth in the high single digits.

Plus, quarterly sales of the company's drugs jumped across the board, with its GLP-1 drug Victoza (liraglutide) and its basal insulin Levemir--which compete's with Sanofi's Lantus--beating expectations.

As for competition driving higher discounts, Novo doesn't see a big change for 2015. The company already lost some ground when Express Scripts booted Victoza and NovoLog (insulin aspart), one of its 'modern insulins,' off its 2014 national formulary. Still, Victoza grew by 20% in North America so far this year, the company said Thursday, despite some loss of coverage by "a large pharmacy benefits manager," a.k.a. Express Scripts.

Last year at this time, the company warned that it could lose 1 percentage point off of 2014 earnings because of formulary changes. The preliminary 2015 forecast issued today takes next year's payer contracts into account, CFO Jesper Brandgaard said during Thursday's earnings call with analysts.

That means Sanofi's unfavorable forecast, which it blamed on the increasing price pressure from U.S. payers, "is mainly its own problem," Sydbank analyst Soren Hansen told Reuters.

Meanwhile, Novo is gearing up with new drugs. Tresiba (insulin degludec), its new basal insulin, is rolling out around Europe, and a new degludec-plus-aspart combination treatment, Xultophy, was approved in Europe last month. Ryzodeg, which combines Tresiba and NovoLog, launched for the first time last month, in Mexico. In Japan, Tresiba has grabbed 24% of the basal insulin market; the drug has launched recently in Brazil, Chile and Russia as well.

In the U.S., the company has run up against some unexpected delays, however. Saxenda, a weight-loss drug with the same active ingredient as Victoza, was set for an FDA decision last week, but the agency hasn't spoken yet. Novo didn't specify when it expects a decision now; an FDA advisory panel backed the drug last month. The company is hoping Saxenda can help boost U.S. growth in the absence of Tresiba, which can't even go up for FDA approval till Novo comes up with new data.

On Tresiba's first run at the FDA, the agency demanded a new study of the drug's safety before approval, and the company has recruited "the majority of patients" for that trial, DEVOTE. The hope was to submit interim data to FDA for approval next year, with a launch in early 2016. Now, the company says it's still mulling over its options, and depending upon the interim data, may wait till the study completes. That would push a potential U.S. launch to 2017.

But don't jump to any conclusions, CSO Mads Krogsgaard Thomsen said during the earnings call. "Our confidence in 'DEVOTE' and the interim analysis is completely unabated and unchanged," he said. "It is just a change in strategy."

- read the Novo release (PDF)
- get more from Reuters

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