Trick or Treat for This Successful Pharma?

Danish pharmaceutical company Novo Nordisk (NYS: NVO) announced its third quarter results on Wednesday. The timing of the announcement on Halloween seems appropriate, because there were both tricks and treats contained in the results. Let's take a look.

Sales increased 20% measured in Danish kroner in the third quarter compared to the same period in 2011. Diluted earnings per share surged 40% compared to last year.

The strongest gains stemmed from Victoza, Novo Nordisk's non-insulin injection for diabetes. Sales for Victoza skyrocketed by 62% year-on-year. The company also saw solid 23% sales growth in its modern insulins, which include NovoRapid, NovoMix, and Levemir.

Two geographic regions produced exceptionally good results for the quarter. Sales in the China region soared 42% compared to last year. North American sales increased by an impressive 32%. The China and North American regions make up 8.4% and 45.3% of total sales, respectively.

These results were certainly sweet, but Novo Nordisk also must pull of a few tricks to continue its success. Approval of the company's new generation insulin drug, Tresiba, ranks as the biggest near-term challenge.

Tresiba has garnered high expectations from Novo and the analyst community. Bloomberg's survey of analysts found that the average estimate is for the drug to hit $9 billion in sales in 2016.

Novo already received approval for Tresiba in Japan. Europe's Committee for Medicinal Products for Human Use also issued a positive recommendation. The challenge, though, is in the U.S. The Food and Drug Administration advisory committee intends to focus on possible cardiovascular risks associated with Tresiba when it discusses the drug on Nov. 8.

The FDA could approve Tresiba but ask Novo to conduct a cardiovascular study after the product is marketed in the U.S. However, the agency could also require the study to be conducted prior to approval. If that decision is made, Tresiba's U.S. launch could be delayed several years.

Should problems arise in the FDA approval process, the primary beneficiary will be Sanofi (NYS: SNY) . Sanofi's Lantus is currently the top-selling long-lasting insulin, with 2011 sales topping $5 billion.

Novo also faces competition from Eli Lilly (NYS: LLY) . Lilly's Humalog and Humulin insulin drugs battle for market share against Novo's products. However, sales for Lilly's two insulin drugs fell in the third quarter because of CVS Caremark (NYS: CVS) dropping them from its formulary.

Merck (NYS: MRK) is another strong contender in the diabetic market. Its Januvia and Janumet drugs grew sales by 15% and 16%, respectively, despite an overall lackluster third quarter.

No fear?
While the scariest prospect for Novo is FDA rejection of Tresiba, some observers don't expect that to happen. Assuming that Tresiba does gain FDA approval, Novo should be poised to continue its winning ways.

Fellow Fool Dan Carroll crowned Novo Nordisk as the best pharmaceutical stock for 2012. And for good reason. The treats from the company's third-quarter results back up Dan's conclusions. If Novo pulls off the tricks lying before it, 2013 could be yet another sweet year.

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