Novo Nordisk and its profit-growth plans hit a roadblock earlier this year when the FDA refused to approve its new diabetes drug, Tresiba, without a new safety study. But CEO Lars Sorensen thinks he has an alternate route through a new weight-loss indication for the already top-selling Victoza.
When can a drugmaker beat earnings expectations and project a 10% boost in profits for the year and still end up disappointing investors? When that drugmaker is Novo Nordisk, the world's largest insulin maker, focused on a rapidly growing treatment area with investors expecting more, more, more.
As new diabetes drug Tresiba inches its way toward approval, Novo Nordisk and rival Sanofi have put up dueling studies and generated dueling headlines. But their rivalry extends beyond those two headlining drugs, Bloomberg reports.
Sanofi had better not get complacent about its place in the diabetes drug market. Novo Nordisk's new chairman still has his sights focused squarely on the the U.S. market where Sanofi's long-acting Lantus now rules supreme.
It is little compensation for being shut out of the U.S. market with its best new product, but Novo Nordisk said it will price Tresiba at a premium in Europe, where the product is facing off against market leader Lantus.
Sanofi's Lantus will remain the heavyweight champion awhile longer. The FDA sent Novo Nordisk back to the training room with its long-acting insulin Tresiba, leaving Lantus unchallenged in its class.
The FDA has handed Novo Nordisk a stunner, ordering the pharma company to complete a new cardiovascular safety study of the long-acting insulin Tresiba before it can be approved in the U.S.
Novo Nordisk racked up some impressive gains in 2012: Sales up 18%, net profits up 25%, EPS up 30%, gross margin up 1.7 percentage points. And the company hiked its forecast for 2013, now that its new diabetes drug Tresiba has won European and Japanese approval--and the company has greater hope for an FDA nod.
Novo Nordisk ($NVO) is ready to roll with its new diabetes drug Tresiba--in Europe, at least. The company won regulatory approval for the potential blockbuster yesterday, setting up a mano-a-mano fight with Sanofi's ($SNY) long-dominant treatment, Lantus.
Lars Sorensen's plans to build Novo Nordisk into one of the world's biggest drugmakers got a big boost with the news that the European Commission has approved Tresiba, its long-acting insulin, which will now be positioned as a rival to Sanofi's megablockbuster Lantus. Novo also gained approval in Europe for the insulin Ryzodeg.